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Medical Devices
CE Marking, Medical Device Regulation Implementation of Medical Device
MDR and IVDR Medical Devices Directive (MDD) to Regulation for CE Marking Training
Medical Devices Regulation (MDR)
Transition training Course
The Medical Devices Regulation (EU 2017/745) has Learn best practice for assembling Technical
replaced the Medical Devices Directive (93/42/EEC) Documentation and QMS when placing Medical
as the legislation detailing the requirements that Devices (MD) on the European Union market.
manufacturers have to meet to place medical The course will also review the requirements of,
devices on the market in the European Union. and relationship between, the legal manufacturer,
Our one day training course has been designed to subcontractors/suppliers, notified bodies, and
introduce medical device manufacturers and other economic operators) according to their obligations
economic operators in the supply chain to the key by MDR.
changes to requirements for CE marking following Duration 3 days
the publication of the new Medical Devices
Regulation (MDR).
Duration 1 day
We understand the challenges of Requirements of the Medical Device Technical Documentation for the MDR Clinical Evaluation for Medical Devices
meeting regulatory requirements Regulation for CE Marking Training Understand the key requirements for technical This course will help you determine if a clinical trial
and maintaining quality Course documentation for medical devices, in line with the is required, prepare a clinical evaluation report and
management systems. Our tutors Learn about the key requirements, concepts, and European MDR. Manufacturers will better determine the requirements for post-market
understand regulatory requirements and Notified
clinical follow-up and post-market surveillance to
the overall process for CE marking under the
are active practitioners in their Medical Devices Regulation (MDR). Body expectations, learning to create robust support continuing compliance.
fields, with years of relevant Duration 1 day technical documentation to demonstrate Duration 1 day
experience and therefore they will compliance to the MDR.
be able to help you improve your Duration 1 day
knowledge of CE Marking, MDR
and IVDR as appropriate to your
needs.
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