Application for Examination of a Quality System according to LVFS 2003:11 (for CE marking o medical devices)
|
|
- Sabrina Cross
- 6 years ago
- Views:
Transcription
1 Company (applicant): hereby applies to, as Notified Body, in accordance with the EG-directive 93/42/EEC (changed 2007/47/EG) for review according to below Review in accordance with 93/42/EEC Annex Annex 2 Full quality assurance 5 Production quality assurance Sterile class I-product Class I measuring function 6 Product quality assurance Class I measuring function The application is regarding New certificate: Revision of certificate No.: Renewal of certificate No. (extension of validity time): Concerning product: Product Concerning quality system: Is the current quality system certified? Yes No If yes, please name -the standard -the certification body Phone: +46 (0) Page 1 (6) For RISE note: Ankom den
2 The applicant confirms: That no corresponding application for conformity assessment covered by this application has been sent to any other Notified Body. That the applicant as the certificate holder allows RISE to publish issued certificates, in listings over certified products. Specific for quality system assessment: That the applicant will fulfill the obligations of the approved quality system; That the applicant will keep the approved quality system valid and effective That the applicant will establish and keep up to date a systematic procedure to review experience gained on products placed on the market, and to implement appropriate means to apply any necessary corrective action. This commitment includes an obligation for us to report accidents and incidents to the MPA in accordance with MDD 93/42/EEC and to follow current recommendations, eg MEDDEV 2.12 / 1, in respect of reporting. Place, date Signature of the person representing the company Clarification/name of the person representing the company This application together with relevant appendix and documentation refererred to in the application is sent to your contact person at RISE according to the model: first_name.last_name@ri.se and to certifiering@ri.se The following information shall be appended: New certificate: If the application is regarding a new certificate documentation in accordance with the appendix shall be appended. Revision: If the application is for revsion of a certificate documentation concerning the changes/additions shall be appended (the appendix can be used as a guide) Renewal of certificate: If the application is regarding renewal of a certificate the following information shall be appended (if relevant) -A description of how the essential requirements have been met -Table of contents of the Technical File -Report regarding risk management -Complete register of articles included in the certificate -List of applied harmonized standards -Example of marking (label etc.) -User manual (in Swedish or English) -Clinical report or clinical or clinical evaluation For sterile products also: -Compilation of sterile validation -Validation of packages Further information of what is needed will be given to you by your contact person at RISE. Page 2 (6)
3 Information about the applicant Legal manufacturer (in accordance with the definition in Law 1993:584 2) Company name: Full postal address: Authorised representative (in accordance with the definition in Law 1993:584 2 g) Invoice address (if other than above) Visiting address: Org./VAT No.: Phone company: company: Internet (www): Contact person: Phone contact person: contact person: Manufacturing places: SNi-code (optional) Information about the manufacturer (if other than applicant): Company name: Full postal address: Visiting address: Org./VAT No.: Phone company: company: Internet (www): Contact person: Phone contact person: contact person: Other information Note If the applicant has activities at several sites or premises or in daughter companies which are part of the scope, we need one register for each of them. Page 3 (6)
4 This is Annex No. 1 Dated: To application dated: Company Signed Documentation required (to be completed by applicant) for review Note: All documentation must be equipped with date and or revision, which is to be updated in case of a new version. Documentation Product description Description or reference (to concerned document/drawing etc.) RISE note The intended use of the device Name to which product category according to LVFS 2003:11, annex 9, the product belongs Name the rationale for the categorization (if you wish, please, append the risk analyses) Name the product code according to Global Medical Device Nomenclature (GMDN): Description of the organization, the amount of employees, ways of manufacturing etc. Name crucial subcontractors used and what services or product they are offering you Do the products contain material of animal origin? If yes, description of the the material Yes No Do the products contain substances from human blood or blood plasma If yes, description Yes No Other information of importance for the mission Page 4 (6)
5 Documentation to be provided with the application: Documentation Quality manual LVFS 2003:11, bilaga 2, 5 resp 6, punkt 3.2 / MDD 93/42/EEC annex 2, 5 or 6 Annex X X X Commitment (Page 2 in this application) X X X Relevant information about the product or product category to which the application relates. The information must contain a general description, intended use, class according to Annex 9 of LVFS 2003: 11, if the product is intended to be combined with other products, etc. X X X Type certificate and accompanying technical documentation (if applicable) X X Planned variants of the product (if applicable) Design drawings, sketches, connection diagrams, including explanations and descriptions X X 1) Description of manufacturing methods X 1) A description of how the essential requirements have been met X (X) (X) Results of design calculations, examinations and performed technical tests, etc. Results of risk analysis together with description of persons who have participated in the risk analysis group A statement of whether the product contains or contains no medicinal product, as well as an indication of relevant tests (X) X X 1) X 1) X 1) Clinical data and trials according to Appendix 10 of LVFS 2003: 11 (if applicable) X 1) Proposals for labeling and, where applicable, operating instructions X 1) 1) This documentation does not need to be attached to the application, but will be requested by RISE for one or more products. (X) May be required for RISE to perform an assessment of the product's class. Page 5 (6)
6 Requirements regarding documentation for medical devices (prior to CE-marking) To ensure a possibility of timely handling of your application for certification of a quality system for medical devices (LVFS 2003:11, annexes 2, 5 or 6), the documentation is expected to be follow the guidance below. Technical documentation When deploying the technical documentation, please use NB- MED/2.5.1/Rec5, rev. 4 (2000), Technical documentation, chapter 4 ( Recommended structure of the technical documentation ). Clinical evaluation It is expected that the devices have been subject to clinical evaluation according to MEDDEV 2.7/1, rev. 4, Clinical evaluation: a guide for manufacturers and notified bodies. Please use the guidance for your documentation The technical documentation should include a clinical evaluation report Biological compatibility Judgment of biocompatibility should be performed according to SS-EN ISO :2009, Biological evalutation of medical devices Part 1: Evalutaion and testing within a risk management process, incl. technical amendment corrigendum 1 (ISO :2009/Cor 1:2010), in particular part 4 ( including part 4 General principles applying to biological evaluation of medical devices and part 7 Interpretation of biological evaluation data and overall biological safety assessment. Risk management Risk management should be performed according to SS-EN ISO 14971:2012 Medical devices -- Application of risk management to medical devices. The risk management report should be according to part 8 ( Risk management report ) in that standard. Essential requirements Compliance to the essential requirements shall be reported in a format clearly showing that all applicable requirements have been considered and handled. In relevant cases it shall be reported how Annex Z in harmonized standards have been managed. Page 6 (6)
GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
MDEG - 2007-12 - II-3.3 MSOGClassIGuidance_Final GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES Foreword These guidance notes do not aim to be a definite interpretation of National Laws and/or
More informationPART 1 DEVICE MASTER FILE
Form-No.: 01 03 00 19e Proposal for a General Product Documentation 0.1 Cover page (company, title, No., release, signature etc.) 0.2 Content (e. g. as document master file) 0.3 General information about
More informationMEDICAL DEVICE. Technical file.
MEDICAL DEVICE Technical file www.icaro-research.eu ICARO MDTF v1.0 1 Mar 2016 1. Do you plan to launch your medical device in Europe? If you re reading this, chances are good that you re considering introducing
More informationMedical Devices. The technical requirements also apply when the submitter is not the legal manufacturer 1 (i.e: a distribution company).
UNFPA Technical requirements for medical devices 1. Introduction The following document provides UNFPA s technical requirements in the procurement of medical devices (medical equipment, renewable medical
More informationGuide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994
Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994 SUR-G0006-2 27 AUGUST 2010 This guide does not purport to be an interpretation of law and/or
More informationMedical Device Directive
Medical Device Directive WG9 - IEC/SC 62A ISO/TC 184/SC 2 Joint Working Group 9 Saeed Zahedi 4 th of July 2012 Blatchford Copyright 2012 Commercial in confidence Definition and Requirements MDD is law,
More informationGuide for Manufacturers and Sponsors on Clinical Investigations Carried Out in Ireland
Guide for Manufacturers and Sponsors on Clinical Investigations Carried Out in Ireland AUT-G0095-1 15 AUGUST 2014 This guide does not purport to be an interpretation of law and/or regulations and is for
More informationChecklist for the assessment based on the standards
ISO & MDD & Checklist for the assessment based on the standards ISO :2016 ISO :2016 associate with EC Directive 93/42 EEC Where applicable EC Directive 93/42/EEC Annex II/V/VI Company: Audit date Auditor:
More informationMedDev and NB-MED Recommendations
Titel of 2.1 Scope, field of application, explanation of terms Guidelines relating to the application of AIMD and MDD: Definition of medical devices, accessory and manufacturer Guidelines relating to the
More informationChanges to the Medical Devices Directive and affect on Manufacturers
TÜV Product Service Ltd Webinar 18 th November 2009 Changes to the Medical Devices Directive and affect on Manufacturers Henry Sibun Manager, Medical & Health Services UK CONTENTS / 1. Introduction 1.
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL LICENCE APPLICATION TO ACT AS WHOLESALER of MEDICAL DEVICES and IVDs An application form for the purpose of obtaining a licence or renewing an existing licence in terms of the
More informationGLOBAL HEALTH SUPPLY CHAIN QUALITY ASSURANCE
GLOBAL HEALTH SUPPLY CHAIN QUALITY ASSURANCE Medical Device Product Questionnaire This questionnaire is used to collect information from vendors with regards to medical devices that fall in any of the
More informationTechnical Documentation
Technical Documentation Helga Seiler M.Sc. Vision Science and Business (Optometry) Manager RA Disclaimer 2 The following list of information is not exhaustive The information and views given in the following
More informationFREQUENTLY ASKED QUESTIONS DURING ELECTRO-MEDICAL DEVICE MARKET ACCESS
FREQUENTLY ASKED QUESTIONS DURING ELECTRO-MEDICAL DEVICE MARKET ACCESS Helping You to Access Global Markets FAST and PREDICTABLY Vishal Thakker, MEng(Hons), AMIMechE Scheme Manager/Product Specialist BSI
More informationInspection of the conduct of clinical evaluations on medical devices in the premises of healthcare providers
ZP-21 Inspection of the conduct of clinical evaluations on medical devices in the premises of healthcare providers This guideline supersedes guideline SÚKL PZT-16 as of November 1, 2004. The purpose of
More informationTo: Prefectural Governors From: Director-General, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
Provisional Translation (as of March 2010) PFSB (Yakushoku) Notification No. 0216002 February 16, 2005 To: Prefectural Governors From: Director-General, Pharmaceutical and Food Safety Bureau, Ministry
More informationEUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY. EudraLex. Volume 4
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Ref. Ares(2015)4234460-12/10/2015 Medicinal products quality, safety and efficacy Brussels, 12 October 2015 EudraLex Volume 4 EU Guidelines
More informationPost Market Surveillance (including PMCF): common non compliances
Post Market Surveillance (including PMCF): common non compliances Jayanth Katta Ph.D Product Specialist & Certification Manager, General Devices Team, Healthcare 1 Overview EU PMS Requirements for Medical
More informationSerious Adverse Event Reporting During European Device Clinical Investigations
regulations and standards Serious Adverse Event Reporting During European Device Clinical Investigations In December 2010, two new European guidelines on medical device clinical studies were published.
More informationGUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN MAKING AN ASSESSMENT OF CLINICAL INVESTIGATION NOTIFICATION
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Cosmetics and Medical Devices MEDDEV 2.7.2 December 2008 GUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN
More informationGUIDELINES ON MEDICAL DEVICES
EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Cosmetics and Medical Devices MEDDEV 2.7/4 December 2010 GUIDELINES ON MEDICAL DEVICES GUIDELINES ON CLINICAL INVESTIGATION:
More informationUNANNOUNCED EU MEDICAL DEVICE AUDITS BY NOTIFIED BODIES: IMPACT ON SUPPLIERS
UNANNOUNCED EU MEDICAL DEVICE AUDITS BY NOTIFIED BODIES: IMPACT ON SUPPLIERS Executive Summary European Medicines Agency (EMA) regulations for licensing of medical devices include the use of authorized
More informationAccessories and other parts for Active Implantable Medical Devices
Notified Bodies Medical Chapter: 2.1 Scope, field of application, explanation of terms Text: Key words: accessories, spare parts, labelling 1 Introduction and purpose With the application of the provisions
More informationEUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL QUESTIONS. and ANSWERS
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, F2/SM D (2008) QUESTIONS and ANSWERS The rules governing medicinal products in the European Union VOLUME 2 NOTICE
More informationNational laws. National Competent Authority / Authorities. Orders, ordinances (supervision)
1 The Regulatory World Only for products classified higher than class I: Notification of the body, Supervision National laws National Competent Authority / Authorities Orders, ordinances (supervision)
More informationDocumentation requirements for an initial consultation
Language : French or English Documentation requirements for an initial consultation Because of the wide range of medical devices which incorporate, as an integral part, an ancillary medicinal substance,
More informationEuropean Packaging Regulations What to expect from a notified body audit of your packaging
What to expect from a notified body audit of your packaging Dr. Ralf Walther TÜV Süd Product Service GmbH March 3-5, 2009 www.healthpack.net Content 1. Short introduction of TÜV Süd Product Service 2.
More informationUpdate on Regulatory Environment- Europe Experience with 2007/47/EC M5 & Discussions on Possible Recast of EU Medical Device Regulations
Update on Regulatory Environment- Europe Experience with 2007/47/EC M5 & Discussions on Possible Recast of EU Medical Device Regulations Paul Brooks Vice President Healthcare, Americas Presentation to:
More informationMEDICAL DEVICES : Guidance document
EUROPEAN COMMISSION DG ENTERPRISE Directorate G Unit 4 - Pressure Equipment, Medical Devices, Metrology MEDICAL DEVICES : Guidance document MEDDEV 2. 1/4 March 1994 GUIDELINES RELATING TO THE APPLICATION
More informationGuide for Ethics Committees on Clinical Investigation of Medical Devices
Guide for Ethics Committees on Clinical Investigation of Medical Devices AUT-G0044-2 04 JUNE 2010 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes
More informationGuidance on the application of mutual recognition in Norway
Guidance on the application of mutual recognition in Norway Under regulation (EC) No. 1107/2009 Norwegian Food Safety Authority Region Office, Greater Oslo Region Official in charge: Tor Erik Jørgensen
More informationAUSTRALIAN MEDICAL DEVICES GUIDANCE DOCUMENT NUMBER 5. The Declaration of Conformity
AUSTRALIAN MEDICAL DEVICES GUIDANCE DOCUMENT NUMBER 5 The Declaration of Conformity 30 October 2003 DISCLAIMER This document is provided for guidance only. It should not be relied upon to address every
More informationWHO Prequalification of In Vitro Diagnostics Programme
P r e q u a l i f i c a t i o n T e a m - D i a g n o s t i c s Information for Manufacturers on the Manufacturing Site(s) Inspection (Assessment of the Quality Management System) WHO Prequalification
More informationOPAC EN Operating Procedure for the Attestation of Conformity of Structural Bearings in compliance with Annex ZA of EN 1337/3/4/5/6/7
OPAC EN1337-00 Operating Procedure for the Attestation of Conformity to EN1337 Revision 00 Approved by BT3 on 20050525, by Board of directors on 20050610 Operating Procedure for the Attestation of Conformity
More informationConformity Assessment of Own Brand Labelling
NBRG/306/06 Co-ordination of Title: Chapter: Conformity Assessment of Own Brand Labelling 2.5.5 Conformity assessment for particular product groups Text: Key words: manufacturer means the natural or legal
More informationMedDev Rev 4 Medical Devices Regulation. Clinical Evidence Requirements Key Changes and Clarifications. Alan Eller 21 March 2017
MedDev 2.7.1 Rev 4 Medical Devices Regulation Clinical Evidence Requirements Key Changes and Clarifications Alan Eller 21 March 2017 Copyright 2016 BSI. All rights reserved. 1 Clinical Evidence Requirements
More informationQualified Persons in the Pharmaceutical Industry. Code of Practice. March 2008
Qualified Persons in the Pharmaceutical Industry Code of Practice March 2008 Updated October 2009 Code of Practice for Qualified Persons 1. INTRODUCTION... 1 2. REGULATORY BASIS FOR THE QUALIFIED PERSON...
More informationTechnical Guidance on Clinical Evaluation of Medical Devices
Annex Technical Guidance on Clinical Evaluation of Medical Devices I. Purpose The clinical evaluation of medical devices is the assessment procedure conducted by registration applicants to validate whether
More informationHOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT 2012 (ACT 737)
MDA/GL No 1: July 2013 Guidelines for implementation of medical device regulatory system HOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT 2012 (ACT 737) [Appendix 4 Schedule 3 Medical
More informationGUIDELINES ON MEDICAL DEVICES
EUROPEAN COMMISSION DG Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies Health technology and Cosmetics MEDDEV 2.7/3 revision 3 May 2015 GUIDELINES ON
More informationGUIDELINES ON MEDICAL DEVICES
Ref. Ares(2016)1982736-26/04/2016 EUROPEAN COMMISSION DG Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies Health technology and Cosmetics MEDDEV 2.7/3
More informationEHPA regulations for granting the international quality label for electrically driven heat pumps
EHPA regulations for granting the international quality label for electrically driven heat pumps Version 1.6 Release 16.02.17 European Heat Pump Association Rue d Arlon 63-67 B-1040 Brussels www.ehpa.org
More informationPost market Surveillance ISO EU Medical Device Regulation
Post market Surveillance ISO13485 2016 EU Medical Device Regulation Patrick Caines, Ph.D. Baxter Healthcare 15 June 2017 Agenda Post market Regulatory Requirements ISO 13485 2016 Summary of key changes
More informationGUIDELINES ON MEDICAL DEVICES
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Pressure equipment, medical devices, metrology MEDDEV. 2.11/1 rev.1 February
More informationRegulatory and ethical requirements in medical device studies. Finland
Regulatory and ethical in medical device studies Finland SECTIONS A.Type of research SECTIONS A.Type of research We have differentiated 8 types of research: Medical device alone with CE mark use within
More informationManual for ITC's Clients 2016 Conformity assessment of in vitro diagnostic medical devices pursuant to Council Directive 98/79/EC
Manual for ITC's Clients 2016 Conformity assessment of in vitro diagnostic medical devices pursuant to Council Directive 98/79/EC Institute for Testing and Certification, Inc., Czech Republic 1. Introduction
More informationThe challenges of software medical device regulation.
The challenges of software medical device regulation. david.grainger@mhra.gov.uk Introduction A brief history of software device regulation A look at the new device regulations 2 Current framework In Vitro
More informationMDR. Device Classification Conformity Assessment Safety & Performance Requirements Technical Documentation
MDR Device Classification Conformity Assessment Safety & Performance Requirements Technical Documentation Suzanne Halliday, D.Phil. Jaishankar Kutty, Ph.D. Ronald Rakos, Ph.D BSI Roadshow, October 2017
More informationMEDICAL DEVICE GUIDANCE DOCUMENT
MDA/GD-0XX June 2015 First Edition MEDICAL DEVICE GUIDANCE DOCUMENT DECLARATION OF CONFORMITY (DoC) Medical Device Authority MINISTRY OF HEALTH MALAYSIA Contents Preface...iii 1 Introduction...1 2 Purpose...1
More informationClinical evaluation report,
Clinical Evaluation Reports from the medical writer s perspective! Gillian Pritchard Sylexis Limited, Dundee, Scotland, UK Correspondence to: Dr Gillian Pritchard Sylexis Limited 30/34 Reform Street Dundee,
More informationCEN Keymark Scheme Rules for Thermostatic Radiator Valves. 2 nd Edition
CEN Keymark Scheme Rules for Thermostatic Radiator Valves 2 nd Edition Content Foreword... 3 Introduction... 3 1 Scope... 4 2 References... 4 3 Terms and Definitions... 4 4 Application... 5 4.1 Product
More informationCSA Group Products, Processes and Services Scheme
1. CONTACT CSA CSA Group Products, Processes and Services Scheme 1.1 Getting started is easy. There are three ways to contact us: Call 866 797 4272 Email client.services@csagroup.org Complete a request
More informationGuideline on the processing of renewals in the centralised procedure
22 June 2012 EMEA/CHMP/2990/00 Rev.4 Committee for Human Medicinal Products (CHMP) Guideline on the processing of renewals in the centralised procedure Transmission to CPMP November 2000 Release for consultation
More informationApplication form UNIVERSITY OF NOTTINGHAM MEDICAL SCHOOL ETHICS COMMITTEE
Application form UNIVERSITY OF NOTTINGHAM MEDICAL SCHOOL ETHICS COMMITTEE In completing this form please refer to the attached Notes of Guidance Application for approval of all studies involving Healthy
More informationClinical Evaluation and Clinical Investigation update MDR
Clinical Evaluation and Clinical Investigation update MDR December 5 th, 2017 Carine Cochereau, Cardinal Health Slide 1 Directives: obligation for Member State (MS) to implement provisions into their national
More informationSUPPLIER QUALITY MANUAL
SUPPLIER QUALITY MANUAL Printed versions of this manual and other Kooltronic supplier documents shall be for reference only and shall be subject to change without notice. It is the responsibility of all
More informationReady or Not: The New Medical Device Regulations Are Here!
Ready or Not: The New Medical Device Regulations Are Here! Felicia R Cochran, PhD, CMPP TM feliciacochran@earthlink.net FR Cochran 1 General Disclaimers This presentation represents the knowledge, professional
More informationRecast Medical Device directives Impacts on materiovigilance
Recast Medical Device directives Impacts on materiovigilance Journée Vigilance 23.03.2017 Valérie Nys Revision of the EU Medical Devices Legislation Directive 90/385/EEC on active implantable medical devices
More informationINSTRUCTIONS FOR CERTIFICATION OF FACTORY PRODUCTION CONTROL
. August 2017 were approved by Manager of Product Certification Bureau of the Polish Register of Shipping on 25 August 2017 Copyright by, 2017. GDAŃSK, AUGUST 2017 1/12 CONTENTS 1. Factory Production Control
More informationCertification Programme No. PCW-12. for construction products System 1, 1+ (certification of constancy of performance) CPR-1,1+
I N S T Y T U T N A F T Y i G A Z U O IL AN D G AS INS TI TUTE PL 31-503 Kraków, ul. Lubicz 25A Tel. +48/12/ 4210033 Fax: +48/12/ 4210050 B I U R O C E R T Y F I K A C J I CERTIFICATION OFFICE Tel. +48/12/
More informationD.P.E.LTD QUALITY CONTROL PROCEDURE NO 9 QUALITY CONTROL REQUIREMENTS FOR SUPPLIERS MASTER COPY
Page 1 of 8 D.P.E.LTD QUALITY CONTROL PROCEDURE NO 9 QUALITY CONTROL REQUIREMENTS FOR SUPPLIERS MASTER COPY REF: DPE/Q.C.P.9 Dated: 19/10/2010 Approved By: P Knight Title: Quality Manager Signed: Page
More informationGuideline on Good Pharmacovigilance Practices Module V- Pharmacovigilance System Master File
Guideline on Good Pharmacovigilance Practices Module V- Pharmacovigilance System Master File Turkish Medicines and Medical Devices Agency 16.02.2015 CHAPTER I... 2 1.1. Introduction... 2 CHAPTER II...
More information(New) Challenges in Clinical Evaluation and Clinical Trials
(New) Challenges in Clinical Evaluation and Clinical Trials Dr. Elisa Hoenig elisa.hoenig@prosystem-cs.com Prosystem AG Beim Strohhause 17 20097 Hamburg Telefon: +49 40 66 87 88-100 Fax: +49 40 66 87 88-199
More information302/2001. Decree of the Council of State. on the conformity assessment of packagings and tanks used for the transport of dangerous goods
Unofficial Translation from Finnish 302/2001 Decree of the Council of State on the conformity assessment of packagings and tanks used for the transport of dangerous goods Adopted in Helsinki, 29 March
More informationPROPOSED DOCUMENT. Global Harmonization Task Force
PROPOSED DOCUMENT Global Harmonization Task Force Title: Quality management system Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange Authoring Group: Study
More informationSingle market, implementation and legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations.
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, implementation and legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Brussels, March 2002
More informationEU MDR Timeline. Dr. Christian B. Fulda Jones Day FDLI Annual Conference Access materials at fdli.org/annual2018
EU MDR Timeline Dr. Christian B. Fulda Jones Day EU MDR - Timeline EU has entered into force, but will only apply for products as of May 26, 2020, with transitional period through 2024/2025? Look closer!
More informationQuality Management System. Manual MASTER COPY
Quality Management System Manual MASTER COPY Revisions: Date Summary Rev. July 2010 14 Oct 2010 28 Jan 2011 9 Feb 2011 9 June 2011 6 March 2012 11 July 2013 13 July 2017 Initial Draft Issued Minor changes
More informationWELMEC European cooperation in legal metrology
WELMEC 8.6 Issue 1 WELMEC European cooperation in legal metrology Measuring Instruments Directive 2004/22/EC Presumption of Conformity of the Quality System of Manufacturers with Module D or H 1 when EN
More informationGuidance on the Application. of ISO / IEC Accreditation International Association for Certifying Bodies
Accreditation International Association for Certifying Bodies Guidance on the Application of ISO / IEC 17020 Guidance on the Application of ISO/IEC 17020 Page 1 of 16 Introduction This guidance document
More informationEUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL GUIDELINES ON MEDICAL DEVICES
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Competitiveness in pharmaceuticals, medical devices, cosmetics MEDDEV. 2.11/1 rev.1 April 2005 GUIDELINES ON MEDICAL DEVICES
More informationPharmacovigilance System Master file
IMPLEMENTING MEASURES IN ORDER TO HARMONISE THE PERFORMANCE OF THE PHARMACOVIGILANCE ACTIVITIES PROVIDED FOR IN DIRECTIVE 2001/83/EC AND REGULATION (EC) NO 726/2004 Pharmacovigilance System Master file
More informationISO 9001:2008 Clause PR017 Customer Satisfaction Procedure
ISO 9001:2008 Clause 8.2.1 PR017 Customer Satisfaction Procedure Strode Park Foundation for People with Disabilities Page 1 of 7 Approvals The signatures below certify that this procedure has been reviewed
More informationMedical Devices. LATVIA LAWIN Klavins & Slaidins
Medical Devices LATVIA LAWIN Klavins & Slaidins CONTACT INFORMATION Sarmis Spilbergs LAWIN Klavins & Slaidins Elizabetes 15, Riga, LV 1010, Latvia +371 67814848 sarmis.spilbergs@lawin.lv www.lawin.com
More informationVerification of Manufactured Products for the IVD Directive
Chapter: 2.5.4 Conformity assessment procedures; Verification of manufactured products Text: Key words: Annex IV-6 and Annex VII-5: In the case of devices covered by Annex II, List A, the manufacturer
More informationGuide to field safety corrective actions for medical devices and in-vitro diagnostic medical devices
Guide to field safety corrective actions for medical devices and in-vitro diagnostic medical devices Item type Authors Publisher Report Irish Medicines Board (IMB) Irish Medicines Board (IMB) Downloaded
More informationImplementing Procedures
Implementing Procedures 1. Certificate of origin Rule 1 Document (a) A certificate of origin should be on ISO A4 size paper in conformity with the format shown in Appendix 1. It should be completed in
More information2. Short description of the industry and the company's activities
Seite: 1 von 6 Please send the completed questionaire via email to zert@berlincert.de or to: Berlin Cert - Prüf- und Zertifizierstelle für Medizinprodukte GmbH Dovestrasse 6 10587 Berlin Fax: 030/314-23719
More informationThe APIC Audit Programme Version 5, July 2017
The APIC Audit Programme Version 5, July 2017 Table of contents 1 General 2. APIC Audit Programme 3 The Auditors 3.1 Educational Background and Experience 3.2 Auditor Training Courses for Certification
More informationMedical Devices Regulation (MDR) Readiness Review
` Medical Devices Regulation (MDR) Readiness Review Company Name Address Certification No. Date: Contact Name Job Title Telephone Email How ready are you for the Medical Devices Regulation? The MDR, which
More informationPOSITION PAPER Moving from the MDD to the MDR
A summary of Key Changes regarding Sterile Packaging and considerations on recommended changes to standards Introduction EN ISO 11607 specifies the requirements and test methods for materials, preformed
More informationMEDICINES CONTROL COUNCIL
PRE-REGISTRATION CONSULTATION MEETING MATERIAL CHECKLIST MEDICINES CONTROL COUNCIL PRE-REGISTRATION CONSULTATION MEETING MATERIAL The CHECKLIST is to be used for the preparation of a formal request to
More informationDue diligence in the European medical devices industry
Due diligence in the European medical devices industry Alison Dennis, Reed Smith LLP www.practicallaw.com/0-205-5707 As the medical devices industry is highly regulated, determining a target company's
More informationTitle Requirements for the accreditation of calibration laboratories
Title Requirements for the accreditation of calibration laboratories Reference RT-25 Revision 05 Date 18-07-2017 NOTE: The present document represents the English version of document under reference at
More informationNational TFS Office, Dublin City Council [NTFSO] Guidance for Completing Notification Document (Annex 1A) & Movement Document (Annex 1B)
National TFS Office, Dublin City Council [NTFSO] Guidance for Completing Notification Document (Annex 1A) & Movement Document (Annex 1B) Introduction A planned shipment subject to the procedure of prior
More informationGuidance for Swedac s assessors on the assessment of laboratories based on the requirements set out in SS-EN ISO/IEC 17025:2005
SWEDAC DOC 02:5 Version 10 2016-05-16 Guidance for Swedac s assessors on the assessment of laboratories based on the requirements set out in SS-EN ISO/IEC 17025:2005 Swedac, Swedish Board for Accreditation
More informationSupplier Quality Manual
including subsidiaries of Mexico and Canada Supplier Quality Manual Issue date: March 1, 2010 Revised: April 7, 2011 Page 1 of 14 Corporate Quality Statement Quality plays a vital role in SCHOTT Gemtron
More informationAAMI Quality Systems White Paper: Comparison of 21 CFR Part 820 to ISO 13485:2016 1
AAMI s White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 February 2017 AUTHORS Seb Clerkin, GMP Advisory Services Nicola Martin, Owner, Nicola Martin Consulting Jack Ward, Owner, Ward Sciences
More informationThe rules governing medicinal products in the European Union. Presentation and content of the dossier Edition
The rules governing medicinal products in the European Union Volume 2B Notice to Applicants Medicinal products for human use Presentation and content of the dossier 1998 Edition EUROPEAN COMMISSION Directorate
More informationThe Pressure Equipment Directive 2014/68/EU. Photo: nostal6ie/ Shutterstock
The Pressure Equipment Directive 2014/68/EU Photo: nostal6ie/ Shutterstock Information for our Customers and Partners. One objective of the EU single market is to ensure the smooth technical transfer of
More informationDGE 2 EUROPEAN UNION. Brussels, 21 March 2018 (OR. en) 2016/0149 (COD) PE-CONS 69/17
EUROPEAN UNION THE EUROPEAN PARLIAMT THE COUNCIL Brussels, 21 March 2018 (OR. en) 2016/0149 (COD) PE-CONS 69/17 POSTES 28 TELECOM 369 MI 974 COMPET 884 DIGIT 285 CONSOM 403 CODEC 2106 LEGISLATIVE ACTS
More informationGuidance Document. RMP Template for Farm Dairies Export Eligible Milk. 11 December 2015
Guidance Document RMP Template for Farm Dairies Export Eligible Milk 11 December 2015 A guidance document issued by the Ministry for Primary Industries Title Guidance Document: RMP Template for Farm Dairies
More informationMedical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS
Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS Key Topics Definitions Essential Principles Classification Conformity Assessment Framework License to Manufacture, Import,
More informationASQ Tappan Zee Section Medical Devices, New Regulations and Standards. 26 th September / V. Fischer / Rev. 01
ASQ Tappan Zee Section Medical Devices, New Regulations and Standards 26 th September / V. Fischer / Rev. 01 Agenda Medical Device, General Aspects Examples Quality System(s) New Regulations & Standards
More informationCOUNCIL DIRECTIVE of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (OJ L 230, , p.
1991L0414 EN 01.02.2007 016.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B COUNCIL DIRECTIVE of 15 July 1991 concerning
More informationGood manufacturing practices
The rules governing medicinal products in the European Union Volume 4 Good manufacturing practices Medicinal products for human and veterinary use 1998 Edition EUROPEAN COMMISSION Directorate General III
More informationFINAL DOCUMENT. International Medical Device Regulators Forum. Medical Device Regulatory Audit Reports
FINAL DOCUMENT International Medical Device Regulators Forum Title: Authoring Group: Medical Device Regulatory Audit Reports IMDRF MDSAP Working Group Date: 2 October 2015 Toshiyoshi Tominaga, IMDRF Chair
More informationi t i s d e c r e e d a s f o l l o w s:
License for the manufacture of drugs for the import of drugs for the wholesale trade of drugs Facts and circumstances Renewal of the license issued on 16 December 2010 for the company,,, company number
More informationISO Standards in Strengthening Organizational Resilience, Mitigating Risk & Addressing Sustainability Concerns
ISO Standards in Strengthening Organizational Resilience, Mitigating Risk & Addressing Sustainability Concerns 13 December 2016 Joe Muratore Copyright 2012 BSI. All rights reserved. Enterprise Risk Management
More information