Qualification: Understanding System Suitability for Intended Use
Differences Between the Revised QMS Ordinance and ISO 13485
Understanding “Implementation Guidelines” in the Revised QMS Ordinance
Full Implementation of the EU Medical Device Regulation (MDR)
Guideline on Determining Medical Device Classification for Software Programs
The Amended GMP Ordinance and International Standards Harmonization
From CSV to CSA: A New Era in Computer System Assurance
The Importance of Clinical Evaluation in Medical Device Development