Navigating Medical Device Regulations – Insights from Our Danish Consultants

Cecilie Bengtsen, Mia Trustrup Larsen, and Nadia Ragnvald Caspersen Key2Compliance has in the past two years expanded its Nordic presence with a dedicated team of regulatory compliance consultants in Denmark. The expansion is timely, given the increasingly stringent compliance requirements for medical devices introduced by the Medical Device Regulation (MDR) and the In Vitro Diagnostic […]

Meet our Coordinating manager for PRRC: Dalia Rhman!

Key2Compliance Coordinating manager for PRRC explains what you need to know about the new required role of Person Responsible for Regulatory Compliance  The new medical device regulations MDR and IVDR have introduced a new role: Person Responsible for Regulatory Compliance (PRRC). According to Article 15 of MDR and IVDR, manufacturers of medical devices are now […]

The Biometrics team – how to use data for insights and success

From left: Albana Shahini, Oskar Öhman, Christina Ehrenkrona, Robert Losif

From left: Albana Shahini, Oskar Öhman, Christina Ehrenkrona, Robert Iosif The foundation of Key2Compliance’s services is to provide customer-oriented solutions that can solve any need of our clients. As an important part of our Clinical Development area, our Biometrics group work with data to provide important insights. Not only to prove that a pharmaceutical or […]