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M5 - Global Quality System Requirements - Implementing ISO 13485 - A Project Management Approach (QP)

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Part of Medical Devices QP Training Module 5

Dates: Tuesday 17 to Wednesday 18 March 2025
Venue:
Manchester - Venue to be confirmed
Cost:

£1470.00 exl VAT

Type: Medical Devices
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About this course

A two day course identifying how to implement ISO 13485 from quality system documentation through to establishing the necessary procedures, records, reviews and processes. We outline the most effective way of implementing ISO 13485 and detail exactly how to project manage an implementation process that will be inspection ready. Full of practical examples, procedures, project plans and simple checklists, this course will enable you to implement the necessary requirements without the need for consultants!

Who Should Attend

Aimed towards professionals responsible for the development of quality management systems for medical devices. The course will certainly benefit new start-up companies as they will be able to implement a quality management system against the requirements of ISO 13485 and CFR21 part 820. Qualified Persons in pharmaceutical manufacturers will find this course highly beneficial if they are working with a new division providing a medical device or if they need to work with a supplier based upon implementation of an effective QMS.

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Bev Willett, Course Administrator, NSF Heath Sciences

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