Clinical Evaluation Training

If you are actively involved with the creation and maintenance of clinical evaluation files, our expert tutors have created this course to enhance your level of understanding on the application of key methods to ensure that the requirements of the new Medical Device Regulation are met.

 

We give you the necessary skills to ensure all the requirements of the law are met and an insight into how the clinical evaluation is integrated with risk management, post-market surveillance, the periodic safety update report, the summary of safety and clinical performance, trending and the CAPA system.

 

By the end of this practical and interactive course, delegates are able to understand the theory of planning, conducting and producing a clinical evaluation report which will meet the requirements of the law. 

Who should attend?

The content will have great value to individuals who are involved in any aspect of implementing or maintaining a clinical evaluation.  

▪    Quality assurance professionals

▪    Quality Engineers

▪    Research and design Engineers

▪    Internal Auditors

▪    Quality Managers

▪    Manufacturing Engineers

▪    Regulatory professionals

Learning objectives include:

▪    Practical use of MEDDEV 2.7.1 rev4

▪    The limits of MEDDEV 2.7.1 rev4

▪    The additional requirements for clinical evaluation imposed by the               Medical Device Regulation

▪    Methods of real-world literature review

▪    Techniques for establishing that sufficient Information is presented               in a clinical evaluation report 

▪    Post-market requirements

▪    How to address continuous updates of a clinical evaluation report                 in a practical way

▪    Conducting post-market clinical

      follow-up

▪    Where clinical evaluation fits in the legal framework 

Only £575

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Download the 2-day Clinical Flyer

2-day Clinical Evaluation Training Course

Date: February 11th 2020 at 8:30am

Venue: 3form Design, The Chapel, Whitchurch, RG28 7LN

Upcoming public course dates:

© 2019 Meddev Solutions Ltd

Company Registration NI645349

Newry

BT34 2DL

United Kingdom

VAT no. 267 7231 82

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