A New ISO Standard for IVD Performance Evaluation Is Taking Shape
Performance evaluation is central to demonstrating conformity under the EU IVDR. To date manufacturers have typically established their performance evaluation frameworks by drawing on the Regulation, MDCG guidance and several standards addressing individual parts of the evidence lifecycle. A new ISO project, currently under development, may eventually provide a more consolidated international reference for performance […]
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 […]