Your Prestigious Partner to reach your business objectives

Transcription

1 Medical Devices Project Management, QA/RA, Lean & Support Services Your Prestigious Partner to reach your business objectives This document or any portion thereof shall not be reproduced or used in any manner whatsoever without the express written permission of Gemar. Copyright Gemar presentation are property of Gemar srl or an affiliate. All rights reserved

2 Mission REGULATORY AFFAIRS & MORE Around the globe, Gemar assists companies both large and small to successfully bring their medical device and IVD products to the market by providing expert regulatory services and strategies throughout the product life-cycle. We help our clients maximize the value of their products by developing innovative and costeffective solutions, tailored to meet the needs and objectives of each and every client. 2

3 Where are we based? In Italy, specifically in Medolla, near to Mirandola which is a small town with a population of about 22,000, located in the extensive plain of Emilia-Romagna, a region in the North of Italy, 200 Km away from Milano, 50 from Bologna and 60 from Verona. Until the sixties Mirandola area had been mostly devoted to agriculture. MILANO Venezia Milano Mirandola Bologna MIRANDOLA Afterwards, on the initiative of a local chemistentrepreneur, a consistent industrial development occurred and the main multinational companies of the medical field invested here. Roma Several leading companies like Fresenius, B.Braun, Baxter, Bellco, Sorin and Medtronic are present with production plants. Also Sandoz, Pfizer have been active here in the past few years. 3

4 Key Milestones Gemar foundation Consultancies on Quality Assurance and Regulatory Affairs for medical devices Based on market request Support on Design Control, Process & Computer System validation Based on market request Support on Maintenance System Management Following market requests Support on Lean Following market requests Support on Energy consumption analysis and Financial Saving Following market requests Import Export for medical devices 4

5 Main Consulting Services Customer Requirements Quality Management System Process and SWvalidation Projects Management Maintenance System Management Regulatory Affairs worldwide for medical devices Lean Energy AccreditationManagement Import-Export medical devices

6 Project Management Gemar can assist you at every step Assess Analyse Design Implement Go live Maintain Business Technical Consulting Project Managent Implementation Training Support 6

7 Project Management Design control milestones Prior art search and non infringement studies Invention disclosure Voice of the Customer methodology (VOC) Users Requirements Analysis to define Uses Specifications Device System and Sub-system analysis Risks Management Prototyping and Bench Testing Design Reviews Verification & Validation, Design Transfer Project Management fulfilling Medical Devices Regulations: Design Control and DHF filing Definition of Regulatory Affairs data from Design 7

8 Regulatory Affairs International & MORE Gemar can assist you at every step of RA activities Regulatory Strategies in EU and RoW Global Regulatory Consulting for Medical Device and IVD Regulatory Gap Analysis Creation of a Regulatory Dossiers Global Medical Device Registration and Approval EC Representative service (AR) US agent service HHS/FDA/CD next 8

9 Regulatory Affairs International & MORE Gemar can assist you at every step RA activities Risk Management File Response to agency queries Agency meetings Advisory Committee preparation Scientific Advice and Protocol Assistance Lifecycle management Input from Subject Matter Experts HHS/FDA/CD 9

10 Clinical Studies Worldwide & MORE Gemar can assist you during Clinical Studies Clinical Investigation Study Design and Protocol Development Clinical Investigation Management for Medical Devices Clinical Evaluation Reports and Literature Review for Registered Medical Devices Clinical Consulting HHS/FDA/CD 10

11 Regulatory Affairs International & MORE We ve got You covered Thanks to our worldwide network, we can initiate your medical devices registration and approval in key markets such, as USA, Canada and Australia as well as Brazil, Russia, India or China. Associate Partner (New Associate York, Partner USA) (New York, USA) Partner Associate (Amsterdam, Netherland) Partner Associate (Angelholm, Partner Associate Sweden) (Angelholm, Sweden) Partner Associate (Munich, Partner Associate Germany) Headquarter (Munich, Germany) (Modella, Headquarter Mo, Italy) (Medolla, Mo, Italy) Partner Associate (Seoul, Partner South Associate Korea) (Seoul, South Korea) Partner Associate (Guangzhou, Partner Associate China) (Guangzhou, China) Partner Associate (Jointville Partner Associate, SC, Brasil) (Jointville, SC, Brasil) 11

12 Quality Management System Gemar can assist you to define your Quality and Risk Management Our experts are there to assist you in setting up your Quality and Risks Management Systems, in compliance with national and international requirements by offering: Development of Quality Management System ISO and US FDA QSR Consulting and Certification for Medical Device Manufacturers Implementation of Pre-production Quality Management System Quality System and GMP audit CMDCAS for Canada medical device registration, Brazilian GMP, Japan PAL, CFDA regulations. MINIMIZE RISK MAXIMIZE QUALITY 12

13 Process Validation & MORE Gemar can assist you to define Process Validation, including: Effective process development (ensuring we fully understand our processes) Design Space (establishing/verifying) Identifying Critical Quality Attributes and establishing Critical Process Parameters and their inter-relationships Quality by Design (QbD) (21 CFR, ISO 13485, ICH Q8 and Q11) Use of Risk Assessment tools Latest regulatory guidance (USFDA, EMA & 2015 EU Volume 4 [GMP] Annex 15 next 13

14 Process Validation & MORE Gemar can assist you to define Process Validation, including: Process Validation approaches for: Small and large molecule Active Pharmaceutical Ingredient (API) manufacture Pharmaceutical products manufacture (fill/finish type activities) Pharmaceutical Packaging Medical Devices and IVD Devices manufacture Maintaining the Validated State Continued Process Verification Statistical process control Quality Systems, e.g. effective change control 14

15 Computer System Validation Gemar can assist you to define CS Validation, including: System specifications Functional specifications Security Back-ups Validation: Hardware Software 15

16 Maintenance System Management Your Total Maintenance System Process is just as important as every other aspect of your production process, and is crucial to the quality of your products. Gemar consultants can assist you with the optimization and management of your maintenance procedures. From data management to performance measurement, we will analyze your current system and provide you with the tools and procedures necessary to ensure that nothing gets in the way of your production goals. next

17 Maintenance System Management Gemar can assist you to define the main steps in maintenance planning, including: Assistance with data migration between maintenance administration systems Performance measurement of maintenance plans Programming optimizations that produce cost savings Optimization of maintenance processes from an Reliability Centered Maintenance (RCM) perspective Revision and/or issuing of SOP for maintenance administration next

18 Maintenance System Management Gemar can assist you to define Your Total Maintenance System Process Client Needs Service Partner Strong Financial impact Solutions for our people Adherence to quality Sustain or improve SLA s Flexible and highly responsive service Gemar Solutions Site & account staffing and contracting approach, reduced transactional complexity Site specific financial savings commitment People on the ground who live there and understand the Client local culture Site specific Quality Protocols and SOP s. Compliance with regulatory, Client and local legislation requirement Common SLA s tailored site weightings and standards A proven governance structure that allows flexibility. A scalable and flexible pricing structure Gemar Evidence Our score has increased year on year globally Savings generated will deliver over the initial 5 year period of the contract We have people across the countries in scope, Services delivered by quqlified suppliers ensures compliance Gemar achieved similar savings without downward adjustment of SLA s An established footprint and high levels of maturity per country allows the service to suit demand Outcomes for Clients 18

19 Lean & MORE Why do embrace Lean? 1. Reduce lead time, turning as quickly as possible customer orders into profit 2. Increase profit by reducing costs and increasing sales 3. Best use of resources, developing simultaneously skills next 19

20 Lean & MORE Gemar can assist you to define Lean Roadmap 1. Approach to improvement, based on the integration of problem solving methods 2. Research and focus on key factors for processes in support of business strategy 3. Optimization, standardization and control of key factors next 20

21 Lean & MORE Gemar can assist you to implement milestones: Lean in the following 1. Performance Assessment : evaluation of current processes and wastes (As Is) 2. Opportunity Definition : identification of opportunities (To Be) 3. Improvement Initiatives : support for the implementation of improvement projects 4. Control of Results : measure of improvement projects efficiency 21

22 Lean & MORE Lean concepts and Tools include: Takt Time Standardized Work One Piece Flow or Continuous Flow Pull Systems and Kanban Five Why's Quick Changeover / Single Mimunite Exchnage of Dies (SMED) Mistake Proofing / Poka Heijunka / Leveling the Workload Total Productive Maintenance (TPM) Five S A-3 Problem Solving / PDCA / PDSA 22

23 Energy Management & MORE Gemar can assist you to define Energy Management Process, including Energy Consumption Analysis and Financial Saving: Establishing a Management System, Energy Audit Energy Saving for Energy-Consuming Systems, e.g.: Power Distribution Systems Lighting Systems Compressed Air Systems Air-Conditioning and Ventilation Systems, Injection-Molding, mixing, filling and packaging Systems 23

24 Import-Export mds & MORE Gemar can assist you to define Your Import-Export service for medical devices Support to identify suppliers and distributors in the EMEA countries Definition of importation procedures from Extra EU countries Definition of Incoming inspections procedures Logistic Management System Management of national public tenders, including review of tender requirements, offers and tenders documents writing, Updating of legal requirements for national tenders 24

25 Questions & answers? 25

26 Contact us & MORE How can we help you? Call or contact us today, we ll be more than glad to answer any questions you might have and find the solution that fits your needs! Gemar s.r.l. Regulatory Affairs & More REGISTERED OFFICE & HEADQUARTER Via G. Puccini, 1 I Medolla (Mo) - Italy Tel. / Fax. +39 (0) Gemar s.r.l. Regulatory Affairs & More BRANCH OFFICE Via G. Amendola, 43 I Medolla (Mo) Italy Tel (0) Fax (0) wecare@gemarmed.com This document or any portion thereof shall not be reproduced or used in any manner whatsoever without the express written permission of Gemar. Copyright Gemar presentation are property of Gemar srl or an affiliate. All rights reserved 26