Ginsbourg.com - Contract Review - Medical Device Verification Qualification

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Ginsbourg.com - Contract Review - Medical Device Verification Qualification

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Ginsbourg.com - Contract Review - Medical Device Verification Qualification

  1. 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. 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. 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. 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

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