Regulatory Challenges for AI-Enabled Medical Devices

QMSR and FDA QSR & ISO 13485 Harmonization

Regulatory Compliance for AI-Enabled Medical Devices

Medical Devices Threat Modeling

EU MDR audit requirements and links to MDSAP program

From “Essential Requirements” to “General Safety and Performance Requirements” – EU MDR 2017/745

Technical Documentation for medical devices under the new European MDR

Conformity Assessment Procedures and Premarket Scrutiny under EU MDR

Classification of medical devices under the European Medical Device Regulation 2017/745

#MDR – Transition periods and definitions

Your insight to: confinis and its partners – work in progress regarding MDR implementation

From Investigator to Consulting: On the other side of the fence

MDR Article 117 – a look into the Crystal Ball (Part 5)

WORKSHOP: PMS under the new European MDR

“Quick Wins” for your MDR implementation

MDR Article 117 – a look into the Crystal Ball (Part 4)

MDR Article 117 – a look into the Crystal Ball (Part 3)

MDR Article 117 – a look into the Crystal Ball (Part 2)

MDR Article 117 – a look into the Crystal Ball (Part 1)

MDR Article 117 – are Combination Product Manufacturers prepared?

Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR): Impact on Switzerland