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Medical Device Directive Services In United Kingdom
7 services found
by:European Device Solutions Limited based inWhitley Bay, UNITED KINGDOM
The new Medical Device Regulation (MDR) comes into force on the 26th May 2021 replacing the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The MDR applies to all manufacturers selling medical ...
Manufactured by:RUA Life Sciences Plc based inAyrshire, UNITED KINGDOM
Our experts offer a consultancy service, which supports your preparation of medical device files and regulatory proposals. The team is world renowned for this work and have global experience of regulatory ...
by:European Device Solutions Limited based inWhitley Bay, UNITED KINGDOM
We have worked with numerous SMEs and Start Ups to develop their Quality Management System (QMS), Technical File and Risk Management Documentation to help them attain a CE Mark for their new medical device(s) in both a timely and cost-effective manner. We have experience of working with all classes of medical device (Class I, IIa, IIb and III) across a wide range of product types. Software as a ...
by:BSI Consulting based inHerndon, VIRGINIA (USA)
BSI Compliance Navigator is the smart, simple way to manage your regulatory information for Medical Device and In Vitro Diagnostic products with EU, UK and US requirements – helping you to get to market faster and maximize your ...
Manufactured by:Nanosonics, Inc. based inSydney, AUSTRALIA
Earle H. Spaulding recognised a disinfection framework was required since all reusable medical devices cannot be sterilized. The Spaulding Classification met a key unmet need that today still forms the basis of international medical device disinfection ...
Manufactured by:Winncare Group based inPresteigne, UNITED KINGDOM
Environment and ISO 14001 certification; The AskleSanté manufacturing site has been located in an industrial area in Grézan in Nîmes since 1995. Specialising in the design and manufacture of medical devices for the prevention and treatment of bedsores, the manufacturing and storage units are classified under the Approval regime in accordance with Classified Installation ...
by:Test Labs Ltd based inPeterborough, UNITED KINGDOM
Test Labs Ltd provides a Medical Device Cleaning Validation service that ensures medical device cleaning protocols, as specified in the Instructions for Use (IFU), are accurately validated. This service is applicable to both manual and automated cleaning methods and complies with international standards such as ISO 17664, ISO 15883, ANSI/AAMI ST98, and ASTM F3208. It involves the use of ...