Week 8 : Medical Device Industry Regulatory Scope for Safety, Quality and Performance [Clutch Moment]

Question 1

What is the main consideration for patient/ public safety?

Answer 1

-Effective post-market surveillance monitoring performance of actual devices under actual usage
conditions
-Management’s Responsibilities on Product Risk Management

Question 2

Describe “medical post-market surveillance”

Answer 2

• A system that provides continuous feedback about a device on the market to maintain a high standard of product Safety and Quality.
• PMS is a regulatory requirement in major markets like Europe and the United States and ASEAN

Question 3

What is under post-market surveillance “proactive”

Answer 3

• Post-approval clinical studies
• Customer surveys
• Expert User focus groups
• Implant Registries

Question 4

What is under post-market surveillance “Reactive”

Answer 4

• Customer complaints
• Maintenance / Service reports
• Detection of manufacturing issues
• Vigilance (FSCA, AE)

Question 5

Some side notes

Answer 5

Big circle : Quality management sytem
inside the big circle (middle circle) : Post Market Surveillance
smallest circle (spilt into 2) : proactive and reactive

Question 6

Describe “Adverse Event Reporting”

Answer 6

In Vitro Diagnostic (IVD) medical devices:
– do not come into contact with patients
– not easy to establish direct harm to patients
AEs involving IVD medical devices will most likely result from a consequence of a medical decision or action taken, or not taken, on the basis of result(s) provided by the IVD medical device

Question 7

Why conduct “Field safety corrective action”

Answer 7

A FSCA is required when it becomes necessary for the manufacturer of the medical device to take action (including recall of the device) to eliminate, or reduce the risk of, the hazards identified.

Question 8

Who can initiate Field safety corrective action

Answer 8

1. Legal manufacturer

2. Regulatory agency