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 required to have a designated person who will be responsible for regulatory compliance (PRRC), ensuring that all post-market surveillance and obligations are […]
What is a MedTech CRO and how can it benefit your company?
Jeanette DemorneyDirector, Clinical Development – GBA Key2Compliance Ever wondered how a MedTech Contract Research Organization (CRO) like GBA Key2Compliance can streamline your journey in the medical device and In Vitro Diagnostic (IVD) landscape? Let’s dive into how our critical support during clinical evaluation and strategic development can propel your project towards success. Understanding the Terminology […]