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Medical Services

The medical device industry is undergoing considerable growth and change as new technologies come into use, increasing regulations and the tightening of definitions for products that bring in more products into the scope of medical device regulations.   Couple these aspects with increasing global competition and the desire to deliver medical devices compliant to global standards and there is an increasing need for independent, flexible, experts support to guide manufacturers to take the best route to compliance, to speed up time to market and keep costs as low as possible.  
Medical Device Total Compliance Solution

A unique and flexible solution for medical device companies and authorised representatives to achieve compliance for their QMS and technical files to meet CE and FDA requirements.

ISO 13485 Compliance

Direct advice and assistance to quickly impelement the necessary QMS for medical device design and manufacture

CE Marking / MDR

Creation and management of Technical File for Medical Device CE Marking including Notified Body interactions

FDA / 21CFR820

Creation and management of Technical File for Medical Device US FDA 510K approvals including  submissions & UL/FCC testing

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