This event is brought to you by Medilink West Midlands and delivered by UL and MasterControl.
You too can be ‘Ready for inspection’
This FREE workshop will cover a number of aspects of compliance related activities and requirements. Together with a brief overview of the applicable regulations for both device manufacturers and component manufacturers, the application of Quality Management processes and systems will also be addressed. The use of these systems in conjunction with effective learning processes and systems will enable companies to be ‘Audit Ready’ state as the new Medical Devices Regulations are implemented.
There will also be a short summary of how Brexit will affect the implementation of the regulations both in the short term and when the UK leaves the UK.
The aim of this workshop is to provide an awareness of the overall requirements for medical devices manufacturers and component manufacturers to ensure audit readiness. This will include:
– A background to the Medical Devices Regulations
– Overview of regulations and standards
– EU medical Devices Regulations
– ISO 13485
– Brexit – the impact
– Audit requirements
– Requirements for Medical Devices
– Requirements for Component Manufacturers
– Quality Management Systems
– Audit readiness
– Risk Assessment
– Case studies/Audit findings as published by the FDA and EMA
To find out more and to book your place, please click here.