Medical  Device  &  QA  Consultancy

Medical Device Safety


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Medical Device & QA Consultancy offers a comprehensive Medical Device Safety service, to help you ensure that your Company's Products meet all the relevant Regulatory, Marketing, Company and Customer requirements, especially concerning control of the Design of your Products.

Safety aspects can be covered to meet all International Regulatory Requirements; eg,

 Medical Device Directive  93/42/EEC;

In Vitro Diagnostic Directive 98/79/EC;

Canadian TPD requirements;

Australian TGA requirements;

 FDA 21 CFR 820.30, QSR Design Control, 510(k) Pre Market Submission), and can include;

 
à Identifying the appropriate Design Input requirements
à Verifying Design Output documents and data
à Conducting Design Verification and Validation, in line with the requirements of
   ISO 9001:2000, ISO 13485:2003 and the above Regulatory requirements
à Design Process effective implementation
à Design Process Regulatory issues
à Hazard Identification and Risk Analysis
à Technical File Compilation and/or Review
à Design Dossier Compilation and/or Review

à Associated Quality System, Document Control and Record Keeping requirements.

 
To discuss any of the above aspects and to determine how Medical Device & QA Consultancy can help you achieve your objectives, please either e-mail Bernard Tremaine at the following address;

bernardt@mdqaconsultancy.co.uk

or follow the Link below and complete the form ...

HOW  TO  CONTACT  US