(PRWEB UK) 11 October 2013
The collaboration will see TRaC providing the electrical testing of medical devices and LRQA will provide conformity assessment services and CE certification under all device classifications.
TRaC provides electrical testing services to IEC/EN 60601-1-2 using UKAS accredited test facilities. Certification to EN 60601 is required in order to comply with the electrical aspects of the medical device directive (MDD), 93/42/EEC.
Together, the two organisations will provide a single solution for those organisations in the electro-medical device sector. Martin Penver, Operations Manager, Medical Devices Team at LRQA comments: “This collaboration will help our electro-medical clients by providing them with a quicker and more straightforward path to market. With over 20 years’ experience as a notified body, we have established an in-depth knowledge and understanding of certification within the medical devices market.
“Our experience of management systems and CE Marking combined with TRaC’s electrical testing capabilities, means we can offer a real alternative in the market to help clients’ meet their regulatory requirements,” Martin concludes.
LRQA is a leading notified body designated under the MHRA (the UK Competent Authority) for the MDD and In-Vitro Diagnostic (IVD) Devices Directive conformity assessment services and CE certification under all device classifications. Additionally, LRQA provide UKAS accredited certification services to ISO 13485, the quality management system certification for medical device manufacturers.