Ginsbourg.com - Medical Software Validation Qualification Questions

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:
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2. ISO 13485 quality management system for the design and manufacture of medical
devices certification since year: ___________________ certified by: ________________
Current level of implementation:
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3. History of FDA submissions and approvals (specify submitted product title, submission
type/class, and granted approval date):
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History of CE submissions and approvals (specify submitted product title, submission
type/class, and granted approval date):
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4. IEC 62304 – medical device software – software life cycle processes certification since
year: ___________________ certified by: ________________
Current level of implementation:
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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:
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6. IEC 60601 safety and effectiveness of medical electrical equipment certification since
year: ___________________ certified by: ________________
Current level of implementation:
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(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 5
B. Specific project information:
1. Which medical device (or production line) currently requires verification and validation?
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2. What is the stated Level of Concern (LOC)? (Please attach)
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3. For medical devices: Is there software within the device? Where? Embedded? Online?
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For medical software or medical devices (or production lines) that contain software:
Which functions are operated by that software (in High level bullets)?
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4. For medical devices: Is there a risk management file for that device? (Please attach)
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Which risk management tool has been implemented?
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Does the above-mentioned risk list already specify software related risks?
________________________________________________________________________
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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?
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For medical software or medical devices (or production lines) that contain software:
Which bug reporting management tool has been implemented?
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6. For medical software or medical devices (or production lines) that contain software:
Is there a Marketing Requirements file? (Please attach)
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Which requirements management tool has been implemented?
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7. For medical software or medical devices (or production lines) that contain software:
Is there a Test Plan file? (Please attach)
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Which test plan management tool has been implemented?
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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?
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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?
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(audits, system validations, audit trails, electronic signatures, and documentation for
software and systems involved in processing electronic data)

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?
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2. Which operating systems are relevant to running the developed software?
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3. Which Integrated Development Environment (IDE) is used for developing the software?
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4. How many developers are programming the software and how many quality testers are
checking each build?
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5. What is the customer attitude on utilizing Open Source tools in the course of developing
and testing the device software? (Recommended)
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Thank you for your cooperation.
Sincerely,
Shay Ginsbourg
Regulatory & Testing Affairs Consultant
WWW.GINSBOURG.COM