1.
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KYIV 2019
Medical software testing —
challenges and opportunities
Kateryna Diadechko
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2.
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Speaker
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Software Test Engineer
Philips IGT Systems
Philips Azurion 7 B12/12

3.
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Regulated industry
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● Business controlled by a government
Energy, healthcare, aerospace, aviation, automotive, etc.
● Economic and social regulation

4.
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Social regulation
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“...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.
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Regulatory authorities
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6.
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Is this a medical device?
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7.
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And this?
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8.
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And this?
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9.
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Medical device
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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.
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Software as a medical device
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● Software in a medical device
(part of, embedded, firmware)
● Software as a medical device
(SaMD)
Butterfly iQ

11.
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Therac-25
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Software that kills
‘Malfunction 54’
1985-1987
6 overdosed
3 died

12.
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Classification
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● General controls, 510(k)
Class I, II, III
● Special controls
Class II
● Premarket approval
Class III

13.
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Code of Federal Regulations (CFR)
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21 CFR
Food and Drugs

14.
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Quality Management System (QMS)
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21 CFR Part 820
Management
Corrective &
Preventive Actions
Material Controls
Design Controls
Records, Documents,
& Change Controls
Production &
Process Controls
Equipment &
Facility Controls

15.
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Design controls
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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.
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Design verification
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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.
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Design validation
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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.
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Design History File (DHF)
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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.
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Challenge 1. Who is the user?
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● Physician
● Nurse
● Patient
● Service engineer
Kokura Memorial Hospital, Japan

20.
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Challenge 2. How is the device being used?
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“Oh my goodness…”

21.
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Does the specification help?
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To some extent…
PLAYMOBIL X-ray Room

22.
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Solutions
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● Meet users
Doctors, patients
● Visit hospitals
● Learn from other functions
System test, validation, field service
● Learn from issues
Engineering issues, product defects, CAPA

23.
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Challenge 3. How to comply to regulation?
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● QMS procedures
Trainings, reviews, approvals
● QMS updates
Recurrent trainings

24.
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Challenge 4. How to provide objective evidence?
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● Sufficient testing?
● Static test basis
Traceability
● Reporting
Documentation

25.
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Solutions
QA CONFERENCE #1 IN UKRAINE KYIV 2019
● Confidence & evidence
● Dynamic test basis
Requirement & test management system
● Generate documentation

26.
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Opportunities
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● Bring value, make a difference
● Cross-functional discipline
● Healthy lifestyle

27.
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Q&A
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