WWW.GINSBOURG.COM
Shay Ginsbourg - Regulatory & Testing Affairs Consultant
57 Kedem St., Jaffa 68176 ISRAEL, E-mail: sgins...
WWW.GINSBOURG.COM
Shay Ginsbourg - Regulatory & Testing Affairs Consultant
57 Kedem St., Jaffa 68176 ISRAEL, E-mail: sgins...
WWW.GINSBOURG.COM
Shay Ginsbourg - Regulatory & Testing Affairs Consultant
57 Kedem St., Jaffa 68176 ISRAEL, E-mail: sgins...
WWW.GINSBOURG.COM
Shay Ginsbourg - Regulatory & Testing Affairs Consultant
57 Kedem St., Jaffa 68176 ISRAEL, E-mail: sgins...
WWW.GINSBOURG.COM
Shay Ginsbourg - Regulatory & Testing Affairs Consultant
57 Kedem St., Jaffa 68176 ISRAEL, E-mail: sgins...
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Ginsbourg.com - Medical Software Validation Qualification Questions

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Transcript of "Ginsbourg.com - Medical Software Validation Qualification Questions"

  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 5 Medical Software Validation Qualification Questions 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 5 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 5 B. Specific project information: 1. Which medical device (or production line) currently requires verification and validation? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 2. What is the stated Level of Concern (LOC)? (Please attach) ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 3. For medical devices: Is there software within the device? Where? Embedded? Online? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ For medical software or medical devices (or production lines) that contain software: Which functions are operated by that software (in High level bullets)? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ______________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 4. For medical devices: Is there a risk management file for that device? (Please attach) ________________________________________________________________________ ________________________________________________________________________ Which risk management tool has been implemented? ________________________________________________________________________ ________________________________________________________________________ Does the above-mentioned risk list already specify software related risks? ________________________________________________________________________ ________________________________________________________________________
  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 5 5. For medical devices (or production lines) that contain software: Which version management tool has been implemented? ________________________________________________________________________ ________________________________________________________________________ For medical software or medical devices (or production lines) that contain software: Which bug reporting management tool has been implemented? ________________________________________________________________________ ________________________________________________________________________ 6. For medical software or medical devices (or production lines) that contain software: Is there a Marketing Requirements file? (Please attach) ________________________________________________________________________ ________________________________________________________________________ Which requirements management tool has been implemented? ________________________________________________________________________ ________________________________________________________________________ 7. For medical software or medical devices (or production lines) that contain software: Is there a Test Plan file? (Please attach) ________________________________________________________________________ ________________________________________________________________________ Which test plan management tool has been implemented? ________________________________________________________________________ ________________________________________________________________________ 8. For medical software or medical devices (or production lines) that contain software: Which HIPPA (Health Insurance Portability and Accountability Act of 1996) requirements are relevant? ________________________________________________________________________ ________________________________________________________________________ 9. For medical software or medical devices (or production lines) that contain software: Which FDA Part 11 (electronic records and electronic signatures) requirements are relevant? ________________________________________________________________________ ________________________________________________________________________ (audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data)
  5. 5. 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 5 of 5 C. Specific software related information: 1. What are the main Marketing Requirements that are relevant to the device software? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 2. Which operating systems are relevant to running the developed software? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 3. Which Integrated Development Environment (IDE) is used for developing the software? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 4. How many developers are programming the software and how many quality testers are checking each build? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ 5. What is the customer attitude on utilizing Open Source tools in the course of developing and testing the device software? (Recommended) ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ Thank you for your cooperation. Sincerely, Shay Ginsbourg Regulatory & Testing Affairs Consultant WWW.GINSBOURG.COM

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