Guidance on De Novo Classification Requests
A De Novo classification request provides a marketing pathway for novel medical devices for whic…
A De Novo classification request provides a marketing pathway for novel medical devices for whic…
Explore detailed Frequently Asked Questions (FAQs) on the Medical Device Rules, 2017, released …
Verification and Validation (V&V) are critical components in the lifecycle of medical devic…
The audit approach undertaken by notified bodies under the CE marking framework for medical dev…
Root Cause Analysis (RCA) is a systematic process used to identify the underlying causes of defe…
Effective recall management is crucial for maintaining patient safety, upholding public trust, …
The Essential Principles of Safety and Performance for medical devices are designed to ensure t…