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Medical Devices
In Vitro Diagnostic Regulation
IVD Directive to IVD Regulation (IVDR) Transition
training course
There are significant changes in the European legislation applicable to IVDs The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC), and will impose new requirements on manufacturers and other Economic Operators
Our one day training course has been designed to introduce IVD manufacturers and other Economic Operators in the supply chain to the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR)
Duration 1 day
Requirements of the In Vitro Diagnostic Regulation
Training Course
Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five year transition period The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors and EU Representatives
CE Marking, MDR and IVDR
Implementation of the In Vitro Diagnostic Device
Regulation for CE Marking Training Course
To help implement the requirements of the European In Vitro Diagnostic Device Regulation (IVDR 2017/746) to obtain and maintain the CE mark for your product Gain confidence with
the IVD classification rules and the conformity assessment routes
Duration 3 days
Technical Documentation for In Vitro Diagnostic Devices
Technical documentation includes the collation of supporting information about your IVD Device and is a required part of conformity assessments and CE Marking This course enables greater understanding of the key requirements for technical documentation for IVDs, in line with the IVDR requirements in Europe Learn how to assemble this and other types of required information so you can CE Mark your device in Europe
Duration 1 day
Performance Evaluation and Clinical Evidence for
In Vitro Diagnostic Devices
This course will enable a greater understanding of performance evaluation for IVD Devices under the IVDR, looking at how this performance fits into the product development lifecycle and IVDR requirements for clinical evidence
Duration 1 day
CE Marking with Software
This course will help you understand how directives apply to your organizations’ software, how software is classified and how to achieve and maintain a CE mark Learn the steps to define, classify, develop and test your medical device software, which is important to keeping your product marketable
Duration 1 day
Duration
1 day
Specialist training
Medical Device Single Audit Program (MDSAP):
Fundamentals and Readiness
This course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where your products are marketed
Duration 2 days
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performance
risk sustainability