Delivering in-house training in EC Directives, ISO 13485, CE Marking, CMDCAS, Gaining US Clearance to Market, CFR 820 QS Regulation  Call Rachel McLean +44(0)1292 671555

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Training

Each Training course and Workshop is designed to meet defined and agreed outputs and are conducted in a manner that engages our delegates.

As appropriate we tailor each course to suit our delegates and to ensure effective practical training we can offer a helpline for a defined period of time post course delivery.

Delivered by both expert and experienced leaders each course is supported by a complete manual containing a copy of presentation slides and reference materials.

Our courses are practical and focused on assisting delegates achieve an understanding of Regulatory Requirements and Standards pertinent to the design, manufacture and distribution of medical devices.

Call Rachel McLean on +44(0)1292 671555 or email rachel@gpb.ltd.uk to discuss your needs.

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Standards

Training delegates in a range of EN, ISO and US Standards for Medical Device design and  risk management.


Regulatory

Delivering courses in EC Medical Device Directives, FDA Regulation and Canadian Medical Device Regulation including Routes to Market.
Training in FMEA and Process Validation.


Documentation

Training and developing delegates in requirements for QS and Regulatory Documentation and  Records including Technical Files and Device Master Records.


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