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Medical Devices
CE Marking, MDR and IVDR
We understand the challenges of meeting regulatory requirements and maintaining quality management systems Our tutors are active practitioners in their fields, with years of relevant experience and therefore they will be able to help you improve your knowledge of CE Marking, MDR and IVDR as appropriate to your needs
Medical Devices Regulation
Medical Devices Directive (MDD) to Medical Devices
Regulation (MDR) Transition training
The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union
Our one day training course has been designed to introduce medical device manufacturers and other economic operators in the supply chain to the key changes to requirements for CE marking following the publication of the new Medical Devices Regulation (MDR)
Duration 1 day
Requirements of the Medical Device Regulation
for CE Marking Training Course
Learn about the key requirements, concepts, and the overall process for CE marking under the Medical Devices Regulation (MDR)
Duration 1 day
Implementation of Medical Device Regulation for
CE Marking Training Course
Learn best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/ suppliers, notified bodies, and economic operators) according to their obligations by MDR
Duration 3 days
Technical Documentation for the MDR
Understand the key requirements for technical documentation for medical devices, in line with the European MDR Manufacturers will better understand regulatory requirements and Notified Body expectations, learning to create robust technical documentation to demonstrate compliance to the MDR
Duration 1 day
Clinical Evaluation for Medical Devices
This course will help you determine if a clinical trial is required, prepare a clinical evaluation report and determine the requirements for post-market clinical follow-up and post-market surveillance to support continuing compliance
Duration
1 day
bsigroup.com/training I 0345 086 9000 I training@bsigroup.com
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