Get Audit Ready: compliance for device and component manufacturers

6 November 2018 Granta Centre, Granta Park, Great Abington, Cambridge CB21 6AL

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 EU.

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

Around the globe, UL works to help customers, purchasers and policymakers navigate market risk and complexity. UL builds trust in the safety, security and sustainability of products, organizations, and supply chains – enabling smarter choices and better lives. In all we do, we apply science and expertise to enable the responsible development, production, marketing and purchase of the goods, solutions and innovations of today and tomorrow.

MasterControl Inc. was founded in 1993 as a document control solution provider. Since that time, the company has grown significantly. Today, MasterControl provides a full line of industry-specific quality and compliance software solutions and services to hundreds of satisfied customers worldwide. Our offerings enable regulated companies to accelerate compliance and get to market faster while reducing costs and improving efficiency.

 

Terms & Conditions: In the event of a no-show or last minute cancellation, the delegate will be invoiced the amount of £40. This covers the cost of the delegates place at this event. On booking this event you are agreeing to these terms & conditions.

To book a place please visit the Eventbrite page

Vanessa Bailey, Events Coordinator, Medilink West Midlands at – vanessab@medilinkwm.co.uk