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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 2The MDR In Depth

Module 3The IVDR In Depth

Module 4MDR/ IVDR Clinical Evidence, specific focus on Clinical data, appraisal of data content, strategic gathering and remediation of GAPs

Module 5MDR IVDR, supply chain and economic operators

Module 6MDR Hazardous substances, risk management and manufacturing considerations.

Module 7MDR/IVDR compliant Quality Systems, labelling and GSPR

For our full training brochure please download the PDF below.