9 product families submitted for approval in timely MDR transition project

Transitioning from MDD to MDR compliance touches on several different business processes – all happening within a strict deadline. Therefore Ambu A/S decided to initiate the process well in advance and team up with Technolution..

Medical device regulations: obstacle or golden opportunity?

Healthtech magazine article shines the spotlight on the challenges and rewards of building your business processes around regulatory compliance.

The highlights of the updated risk management standard

What you need to know about the updates to the 2019 version of ISO 14971.