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KYIV 2019
Medical software testing —
challenges and opportunities
Kateryna Diadechk...
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Speaker
QA CONFERENCE #1 IN UKRAINE KYIV 2019
Software Test...
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Regulated industry
QA CONFERENCE #1 IN UKRAINE KYIV 2019
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Social regulation
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Regulatory authorities
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Is this a medical device?
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And this?
QA CONFERENCE #1 IN UKRAINE KYIV 2019
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And this?
QA CONFERENCE #1 IN UKRAINE KYIV 2019
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Medical device
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Federa...
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Software as a medical device
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Therac-25
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Software th...
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Classification
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● Gene...
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Code of Federal Regulations (CFR)
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Quality Management System (QMS)
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Design controls
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Desig...
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Design verification
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Design validation
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Design History File (DHF)
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Challenge 1. Who is the user?
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Challenge 2. How is the device being used?
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Does the specification help?
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Solutions
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● Meet user...
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Challenge 3. How to comply to regulation?
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Challenge 4. How to provide objective evidence?
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Solutions
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Opportunities
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Q&A
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QA Fest 2019. Екатерина Дядечко. Тестирование медицинского софта — вызовы и возможности

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Проектирование и производство медицинских устройств — это регулируемый бизнес. Государственные органы во всем мире призваны гарантировать безопасность и эффективность медицинских устройств. Несоответствие нормативным требованиям ставит под угрозу жизнь и здоровье человека. Как медицинское регулирование влияет на рабочий процесс компании производителя? Мы поговорим о том, какие вызовы стоят перед тестировщиком медицинского софта, а также какие возможности при этом открываются.

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QA Fest 2019. Екатерина Дядечко. Тестирование медицинского софта — вызовы и возможности

  1. 1. Тема доклада Тема доклада Тема доклада KYIV 2019 Medical software testing — challenges and opportunities Kateryna Diadechko QA CONFERENCE #1 IN UKRAINE
  2. 2. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Speaker QA CONFERENCE #1 IN UKRAINE KYIV 2019 Software Test Engineer Philips IGT Systems Philips Azurion 7 B12/12
  3. 3. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Regulated industry QA CONFERENCE #1 IN UKRAINE KYIV 2019 ● Business controlled by a government Energy, healthcare, aerospace, aviation, automotive, etc. ● Economic and social regulation
  4. 4. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Social regulation QA CONFERENCE #1 IN UKRAINE KYIV 2019 “...opening the glove box and turning on the emergency lights — jobs required by law to be performed with physical buttons” ‘Elon Musk: Tesla, SpaceX, and the Quest for a Fantastic Future’ by Ashlee Vance Tesla Model S
  5. 5. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Regulatory authorities QA CONFERENCE #1 IN UKRAINE KYIV 2019
  6. 6. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Is this a medical device? QA CONFERENCE #1 IN UKRAINE KYIV 2019
  7. 7. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY And this? QA CONFERENCE #1 IN UKRAINE KYIV 2019
  8. 8. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY And this? QA CONFERENCE #1 IN UKRAINE KYIV 2019
  9. 9. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Medical device QA CONFERENCE #1 IN UKRAINE KYIV 2019 Federal Food Drug & Cosmetic Act, 201(h) An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article ● intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease ● intended to affect the structure or any function of the body
  10. 10. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Software as a medical device QA CONFERENCE #1 IN UKRAINE KYIV 2019 ● Software in a medical device (part of, embedded, firmware) ● Software as a medical device (SaMD) Butterfly iQ
  11. 11. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Therac-25 QA CONFERENCE #1 IN UKRAINE KYIV 2019 Software that kills ‘Malfunction 54’ 1985-1987 6 overdosed 3 died
  12. 12. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Classification QA CONFERENCE #1 IN UKRAINE KYIV 2019 ● General controls, 510(k) Class I, II, III ● Special controls Class II ● Premarket approval Class III
  13. 13. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Code of Federal Regulations (CFR) QA CONFERENCE #1 IN UKRAINE KYIV 2019 21 CFR Food and Drugs
  14. 14. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Quality Management System (QMS) QA CONFERENCE #1 IN UKRAINE KYIV 2019 21 CFR Part 820 Management Corrective & Preventive Actions Material Controls Design Controls Records, Documents, & Change Controls Production & Process Controls Equipment & Facility Controls
  15. 15. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Design controls QA CONFERENCE #1 IN UKRAINE KYIV 2019 Design Reviews & Changes User Needs Design Input Design Process Design Verification Design Output Medical Device Design Validation Design History File (DHF) 21 CFR Part 820.30
  16. 16. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Design verification QA CONFERENCE #1 IN UKRAINE KYIV 2019 21 CFR 820.3 (aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. 21 CFR 820.30 (f) The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.
  17. 17. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Design validation QA CONFERENCE #1 IN UKRAINE KYIV 2019 21 CFR 820.30 (g) Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.
  18. 18. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Design History File (DHF) QA CONFERENCE #1 IN UKRAINE KYIV 2019 21 CFR 820.30 (j) Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. DHF is a summation record of all design actions from start to transfer including changes.
  19. 19. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Challenge 1. Who is the user? QA CONFERENCE #1 IN UKRAINE KYIV 2019 ● Physician ● Nurse ● Patient ● Service engineer Kokura Memorial Hospital, Japan
  20. 20. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Challenge 2. How is the device being used? QA CONFERENCE #1 IN UKRAINE KYIV 2019 “Oh my goodness…”
  21. 21. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Does the specification help? QA CONFERENCE #1 IN UKRAINE KYIV 2019 To some extent… PLAYMOBIL X-ray Room
  22. 22. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Solutions QA CONFERENCE #1 IN UKRAINE KYIV 2019 ● Meet users Doctors, patients ● Visit hospitals ● Learn from other functions System test, validation, field service ● Learn from issues Engineering issues, product defects, CAPA
  23. 23. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Challenge 3. How to comply to regulation? QA CONFERENCE #1 IN UKRAINE KYIV 2019 ● QMS procedures Trainings, reviews, approvals ● QMS updates Recurrent trainings
  24. 24. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Challenge 4. How to provide objective evidence? QA CONFERENCE #1 IN UKRAINE KYIV 2019 ● Sufficient testing? ● Static test basis Traceability ● Reporting Documentation
  25. 25. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Solutions QA CONFERENCE #1 IN UKRAINE KYIV 2019 ● Confidence & evidence ● Dynamic test basis Requirement & test management system ● Generate documentation
  26. 26. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Opportunities QA CONFERENCE #1 IN UKRAINE KYIV 2019 ● Bring value, make a difference ● Cross-functional discipline ● Healthy lifestyle
  27. 27. Тема доклада Тема доклада Тема доклада WITH PASSION TO QUALITY Q&A QA CONFERENCE #1 IN UKRAINE KYIV 2019

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