Module 16 2024

10/17/2024

Post-Market Clinical Follow up – What to look for?

Quantification of Residual Risks

Usability

Unanswered Questions

PMCF (Yes/No)

Medium- and Long-Term Safety

Side-effects and contraindications

Medium- and Long-Term Performance

Rare Complications

Courtesy of TÜV SÜD Product Service

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

45

45

Post-Market Clinical Follow up – Methods

Courtesy of TÜV SÜD Product Service

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

46

46

23