If you have your own regulatory team, Sensus can supply full training to ensure they are up to date with the full regulations and compliance documentation.
Module 1 – Foundation Module, Basic skills, project and time management, company records/formats, report writing and MDR overview*
Module 2 – The MDR In Depth
Module 3 – The IVDR In Depth
Module 4 – MDR/ IVDR Clinical Evidence, specific focus on Clinical data, appraisal of data content, strategic gathering and remediation of GAPs
Module 5 – MDR IVDR, supply chain and economic operators
Module 6 – MDR Hazardous substances, risk management and manufacturing considerations.
Module 7 – MDR/IVDR compliant Quality Systems, labelling and GSPR
For our full training brochure please download the PDF below.