The IVDR regulates everything: from development to market surveillance, application, and the requirements that in vitro diagnostic devices must meet. The regulation is directed at manufacturers, importers, users, notified bodies, and national authorities
Give your employees the opportunity to always stay up to date!
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General safety and performance requirements for in-vitro diagnostics
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Requirements & processes for the development of medical devices and IVDs
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Basic course ISO 13485:2016 – Quality management for medical devices & IVDs
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basic course IVDR
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ISO 14971:2019 – Risk management for medical devices & IVDs
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Clinical performance evaluation of IVDs
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Labelling and Unique Device Identification (UDI)
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MDR or IVDR gap analysis
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Technical documentation for MP & IVD according to MDR / IVDR
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Post-market surveillance: Post Market Surveillance
