Production of medical devices is a strictly regulated business. In almost all countries, and for most medical products, there are requirements and standards to which manufacturers need to show compliance.
Clinical Evaluation Plan and Report
Design Control for Medical Devices
Introduction to biocompatibility for medical devices
Introduction to IVDR EU 2017/746 In Vitro Medical Device Regulation
Introduction to MDR EU 2017/745 Medical Device Regulation
ISO 13485:2016 and MDR Internal Auditor Course
ISO 13485:2016 Foundation Course
ISO 13485:2016 Internal Auditor Course
ISO 13485:2016 Lead Auditor Training for Medical Device industry
MDR training
MDSAP - Medical Device Single Audit Program
Person Responsible for Regulatory Compliance (PRRC)
Post Market Surveillance
