Tag: regulatory

Welcome to join Innokas Medical and Key2Compliance´s Good Morning Meeting at Medicon Valley!

Optimal Regulatory and Design Development from Idea to Success of a Medical Device To succeed in taking a medical device product from idea to the market, both the design and development flow, as well as the regulatory flow need to be considered. As the inventor or manufacturer of a medical device, a key success factor […]

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 […]