We outline the key steps and components necessary for creating a comprehensive project plan for medical device development.
Category: Patrick Gora
EU MDR and Clinical Evaluation: Navigating New Expectations for Safety and Performance
We explore the core principles of clinical evaluation under EU MDR, key challenges, and strategies for compliance.
Sterilization Validation in Medical Devices: Meeting Regulatory Standards for Safety
We delve into the importance of sterilization validation, the key methods used, and the regulatory standards that manufacturers must adhere to.