1. Testing Medical Devices A Brief Overview © 2005 Max Cortner. Copying and distribution of this document is permitted in any medium, provided this notice is preserved.

2. 2 Food and Drug Administration Authority in the US Criminal penalties for promoting unapproved drugs or devices CDRH reviews and approves Similar but more stringent than EU ISO approach Quality System 21 CFR Part 820 Must Prove Safety and Efficacy

3. 3 Design Controls for Class II Devices Planning,Input, Output, Review Design Verification Design Validation Design Transfer (to manufacturing) Design Change Procedure Design History File – documents to show design complies

4. 4 Design Verification Design Output Meets Design Input Requirements Identification of design (configuration mgmt) Methods Date Individual performing tests

5. 5 Typical Design Verification Operating Range Battery voltages Telemetry (range, speed, error rate) Temperature range Internal Specs Bus characteristics Memory operation (speed, errors) Sense amp operation (gain, BW, noise)

6. 6 Design Validation Design Conforms to User Needs and Intended Use Performed under defined operating conditions (initial production lots) Actual or simulated use conditions Software validation Risk analysis Records similar to verification

7. 7 Typical Design Validation External Interface Specs Indicator or display operation Blood pressure sensitivity, linearity, accuracy Simulated Use Scenarios from users manual w/options Random inputs or error response scenarios

8. 8 Proving Safety Clinical Trial (p People for d Days) Compare to Existing Approved Devices Engineering Analysis Identify Potential Risks Hazards and mitigation FMEA Biocompatibility analysis of materials

9. 9 Proving Efficacy Intended Use Describe diagnostic or therapeutic value Identify Standard of Care for comparison Blood pressure cuff Claims Parameters – labeling Functions Useful life Accuracy

10. 10 Device History Record Requirements Peer Review Design Details Design Verif. Design Valid. Peer Review V&V Report Version Control and History on ALL

11. 11 Test Plans Detail repeatable by an independent individual of similar skill (Electrical Engr) Set-up including equipment required Measurement or observation to be made (beware of observations) Criteria for pass clearly defined

12. 12 Test Reports Original data must be maintained! Signed Dated Indelible ink, no obliteration of changes Record instrument models, s/n, and calibration dates Document setup (schematic)

13. 13 Software Test Requirements, Plan, Report (all peer reviewed in that order) Methods of test tailored to fit complexity code reviews unit testing software test bench exercises integration testing with scenarios Independence of review and test

14. 14 Risk Management Patient Safety Risk is Paramount in Decision Making! Must be considered in hardware and software testing Explicitly state risk in design docs Consider risk in peer reviews How much testing is optional once the patient safety requirements satisfied