Medical  Device  &  QA  Consultancy

.Medical Device Compliance Review

Have you recently ......

 

à Had MHRA notification of a pending audit of your Technical File................?

à Failed a Medical Device Directive 93/42/EEC Audit ?

à Received an Enforcement Letter from the MHRA ?

 

If you need help to address any of the above issues, please e-mail:

Bernard Tremaine at: e-mail: info@mdqa.co.uk        

giving brief details of the communication from the MHRA + your Name + Telephone number, and someone will call you back to discuss how we can help you effectively address the MHRA's concerns.

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or are you extending your Product Range to include...

 

à Higher Risk Devices ?

à Devices that require 'Formal' Design Control (ISO 9001:2000 or ISO 13485:2003) ?

à Devices that are Class III and therefore require a Design Dossier ?

 

 

or you have an …

 

à FDA 21 CFR 820 Compliant Quality System, but now need to address the Design Control aspects (21 CFR 820.30) which were mandatory from July 1998 !

 

If any of the above apply to your Company, please feel free to call or e-mail to discuss any of the above aspects IN TOTAL CONFIDENCE and to determine how Medical Device & QA Consultancy can help you achieve your objectives.

 

 

Track Record….

 

Medical Device & QA Consultancy has a Track Record second to none. A more detailed Company Profile is available.