Questionnaire for a Quotation (Medical Devices)

Transcription

1 Details of the Company Company (Name and Legal Entity) Street Postal Code, Place Country Homepage -Address (Company) Phone (Switchboard) Fax (Company) Company VAT (TVA) ID number Main site (address for the certificate) Main contact person Title Mr. Ms. Dr. First and Last Name Position Direct phone Direct fax Mobile phone Personal -Address If the company is based in non-eu countries (except EFTA countries, Switzerland and Turkey) Address of the authorized representative based in the EU Company Name Legal Entity Street Country Postal Code Place Salutation Mr. Ms. Title First and Last Name Position Direct phone Direct fax Mobile phone -Address The national registration number of the EU representative: Short description of the company s activities and branch: Desired scope of the certificate(s): Area of aimed certification the whole company the following particular parts: Aimed Scope of Certification Standard / Directive European Medical Device Directive 9//EEC (Please also complete both pages of Annex I) Annex II Annex V Annex VI ZLG EN ISO 8 DAkkS EN ISO 900 DAkkS EN ISO 8 with reprocessing of medical devices (RKI ) (Please also complete Annex II) Accreditation/Acceptance DAkkS EN ISO 8 with additional acceptance in Taiwan under the TCP ISO 8 MDSAP with additional acceptance in Canada/USA/Brazil/Japan/ Australia In co-operation with DQS Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten DAkkS Deutsche Akkreditierungsstelle GmbH - German Association for Accreditation GmbH RKI-Empfehlung: Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten. Technical Cooperation Programme on Exchange of Medical Device GMP and ISO 8 Audit Reports DQS Medizinprodukte GmbH 9_7b8b6d7-68-9a9-9dc9-88aab0.docx Page of

2 Information on your existing quality management system Is your quality system certified? (If yes, please add copies of your certificates!) If yes, by which Notified Body/registrar? If yes, when does the validity of your certificate(s) end? Your desired period for the audit? In which languages can the audit be conducted? No In which language is the technical documentation available? German English Other External consulting companies Were you assisted in implementation or maintenance of the quality system by an external consulting company? If yes, please provide all involved consulting companies (company name, location) No Subsidiaries, branch offices, production sites and further sites which are covered by the quality system Number of Employees Location Address and legal entity (Please copy this page in case there are more than sites) Fulltime Part time External sales Others Temporary workers (average/year) Trainees Shift work Total Distribution of employees in organizational areas (Please copy this page in case there are more than sites) Location Business area (Please add an organization chart of your company) Design and development Manufacturing / Production and warehouse Repair or Reprocessing of medical devices Quality management / Quality control / Regulatory Affairs Marketing, distribution and field service Administration and other Total Details of shift work (If applicable) Is your company working in shifts? No Number of Employees in shifts: If yes, what kind of shift model? -Shift -Shift Other: Are certain activities outsourced to external parties? (e.g. part production) If yes, which activities are outsourced? No NOTES ON DATA PROTECTION: The processing of the personal data communicated in this questionnaire takes place at the request of the signatory/the submitting person for the purpose of pre-contractual measures (preparation of offers) and, if necessary, for the execution of a coming contract according to Art. 6 Para. lit. b GDPR. For any further use of personal data, the consent of the data subject is regularly required. You can give such consent in the following section. Further information on data protection can be found in our data protection declaration online at and in our document "Data protection information for customers and interested parties". Consent to the use of personal data for the purpose of information about services and news about the certification environment (If you agree with the purpose of use, please tick this accordingly. If you do not wish to give your consent, please leave these fields blank). Please inform me, independent of the certification procedure, about other aspects and news about the certification environment for medical devices and health care as well as about your seminars on the subject: yes, gladly by post yes, gladly by (please do not forget to include your address) In accordance with data protection legislation, you have the right to information, correction, restriction and deletion of your personal data. In addition, you have the right to revoke your consent at any time and without giving reasons. If you wish to exercise any of these rights or have any further questions about data protection, please send an to datenschutz@mdc-ce.de Please click here to enter a date Place, Date Signature or full name 9_7b8b6d7-68-9a9-9dc9-88aab0.docx Page of

3 Annex I Only with the desired certification of medical devices according to MDD 9//EEC (Please also complete this and the following page) A) Information about the products (Please attach further product information (product description / user manual) to the table below) Product or product group name Class Rule OEM- Product 6 OEM Case 7 (Please copy this page if there are more than products within the certification scope!) Are the above mentioned products with the following features: Product sterile medical devices (sterilization by moist heat- EN ISO 766) (MDS 7006) sterile medical devices (sterilization by ethylene oxide EN ISO ) (MDS 7006) sterile medical devices (sterilization by irradiation EN ISO 7) (MDS 7006) sterile medical devices (other sterilization methods) (MDS 7006) active medical devices (driven by energy) medical devices with a measuring function medical devices incorporating a drug (MDS 700) medical devices incorporating materials of animal origin medical devices manufactured and incorporating materials with origin of species bovine, sheep, goat, deer, elk, mink or cat (MDS 700) Medical devices referencing Directive 006//EC on machinery (MDS 700) Medical devices utilising nanomaterials (MDS 7008) Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed (MDS 7009) Medical devices incorporating software/ utilising software/controlled by software (MDS 700) Medical devices incorporating derivates of human blood according to Directives 000/70/EC and 00/0/EC (MDS 700) (Notice: Not in the scope of our notification) Medical devices utilising micromechanics (MDS 7007) 6 These are products that are placed on the market under the name of your company but are sourced as "ready to sell" products from an "Original Equipment Manufacturer" 7 The various possible OEM case constellations can be found in the original document EK-Med Beschluss.9 B6 Zertifizierung von OEM-Produkten respectively 9_7b8b6d7-68-9a9-9dc9-88aab0.docx Page of

4 B) Information about subcontractors / critical suppliers / OEM suppliers Please copy this page if more than products are certified or more than subcontractors / critical suppliers or OEM suppliers are involved! Are you using significant subcontractors / critical suppliers or OEM suppliers? No Product Name and address of subcontractors/ critical suppliers/ OEM suppliers Commissioned activity Certified? Please include all currently valid certificates from your subcontractors / critical suppliers or OEM suppliers 8 These are products that are placed on the market under the name of your company but are sourced as "ready to sell" products from an "Original Equipment Manufacturer" 9_7b8b6d7-68-9a9-9dc9-88aab0.docx Page of

5 Annex II Only with the desired certification of with reprocessing of medical devices A) Details of the reprocessing of medical devices Information concerning the reprocessing methods (e. g. Decontamination (EN ISO 88- ff.), Steam sterilization (EN ISO 766- ff.), Sterilization by ethylene oxide (EN ISO ff.), H O Plasmasterilization (EN ISO 97 ff.) etc.) Type of reprocessing-/ cleaning-/ sterilization process Number of devices/areas B) Information concerning the classification of risk according RKI 9 - Guidelines Please indicate the classification of risk of the medical devices to be reprocessed Critical A Critical B Critical C (Is not offered by mdc) C) Information about the products Product or product group name Reprocessing intended by manufacturer? Reprocessing-/ Sterilization method No No No No No 6 No 7 No 9 No 0 No No No Attachment: Screening-List (file designation) Attachment: Set-List (file designation) Attachment: Organizational chart with naming of disciplines/areas (file designation) 9 Empfehlung Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten. des Robert-Koch-Instituts (RKI) 9_7b8b6d7-68-9a9-9dc9-88aab0.docx Page of