Meet Oscar He, our Senior Consultant and Coordinating Manager for internal audits!

Oscar He

Internal audits – an opportunity to improve medical devices Internal audits are an important activity for medical device manufacturers. They are not only a requirement for ISO 13485 compliance, but also an opportunity to get valuable feedback that can help to improve both the medical device and the development process. Oscar He is coordinating the […]

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 […]