ISO 13485 Medical Device Contract Review
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This document is a contract review for medical device verification and qualification that contains questions to gather information about a company's quality management systems, certifications, regulatory submissions and approvals, and specific details about a medical device or production line that requires verification or validation. It requests details about ISO and IEC certifications, FDA and CE marking history, whether the device contains software and risk management processes, as well as information on requirements management, test planning, and Part 11 compliance for electronic records if applicable. The review is intended to assess the company's quality level and prepare for a verification or validation project.
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ISO 13485 Medical Device Contract Review
- 1. WWW.GINSBOURG.COM Shay Ginsbourg - Regulatory & Testing Affairs Consultant 57 Kedem St., Jaffa 68176 ISRAEL, E-mail: sginsbourg@gmail.com, Tel: +972 (0)54 6690915 Page 1 of 4 Contract Review - Medical Device verification qualification A. Company info and general quality level classification: 1. Company name and website: ________________________________________________________________________ ________________________________________________________________________ 2. ISO 13485 quality management system for the design and manufacture of medical devices certification since year: ___________________ certified by: ________________ Current level of implementation: ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 3. History of FDA submissions and approvals (specify submitted product title, submission type/class, and granted approval date): ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ History of CE submissions and approvals (specify submitted product title, submission type/class, and granted approval date): ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 4. IEC 62304 – medical device software – software life cycle processes certification since year: ___________________ certified by: ________________ Current level of implementation: ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________
- 2. WWW.GINSBOURG.COM Shay Ginsbourg - Regulatory & Testing Affairs Consultant 57 Kedem St., Jaffa 68176 ISRAEL, E-mail: sginsbourg@gmail.com, Tel: +972 (0)54 6690915 Page 2 of 4 5. ISO/IEC 12207 Systems and software engineering — Software life cycle processes certification since year: ___________________ certified by: ________________ Current level of implementation: ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 6. IEC 60601 safety and effectiveness of medical electrical equipment certification since year: ___________________ certified by: ________________ Current level of implementation: ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ (The third edition of 60601-1 offers general requirements for basic safety and essential performance of medical electrical equipment) 7. ISO 14971 Risk management for medical devices certification since year: ___________________ certified by: ________________ Current level of implementation: ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________
- 3. WWW.GINSBOURG.COM Shay Ginsbourg - Regulatory & Testing Affairs Consultant 57 Kedem St., Jaffa 68176 ISRAEL, E-mail: sginsbourg@gmail.com, Tel: +972 (0)54 6690915 Page 3 of 4 B. Specific project information: 1. Which medical device (or production line) currently requires verification or validation? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 2. For medical devices: Is there software in the device? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ Which of the medical device functions are operated by that software? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 3. For medical devices: Is there a risk management file for that device? ________________________________________________________________________ ________________________________________________________________________ Which risk management tool has been implemented? ________________________________________________________________________ ________________________________________________________________________ Does the risk list specify software related risks? ________________________________________________________________________ ________________________________________________________________________ 4. For medical devices (or production lines) that contain software: Which version management tool has been implemented? ________________________________________________________________________ ________________________________________________________________________ 5. For medical devices (or production lines) that contain software: Which bug reporting management tool has been implemented? ________________________________________________________________________ ________________________________________________________________________ 6. For medical devices: Is there a Marketing Requirements file? ________________________________________________________________________
- 4. WWW.GINSBOURG.COM Shay Ginsbourg - Regulatory & Testing Affairs Consultant 57 Kedem St., Jaffa 68176 ISRAEL, E-mail: sginsbourg@gmail.com, Tel: +972 (0)54 6690915 Page 4 of 4 ________________________________________________________________________ Which requirements management tool has been implemented? ________________________________________________________________________ ________________________________________________________________________ 7. For medical devices: Is there a Test Plan file? ________________________________________________________________________ ________________________________________________________________________ Which test plan management tool has been implemented? ________________________________________________________________________ ________________________________________________________________________ 8. For medical devices that contain software: Part 11 electronic records and electronic signatures requirements: ________________________________________________________________________ ________________________________________________________________________ (audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data) Thank you for your cooperation. Sincerely, Shay Ginsbourg Regulatory & Testing Affairs Consultant WWW.GINSBOURG.COM