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.
Areas of training covered include, but are not limited to:
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.