TRaC Global and LRQA have formed a collaboration to provide a single solution for those organisations in the electro-medical device sector.
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 EMC aspects of the medical device directive (MDD), 93/42/EEC.
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.
Under the collaboration, TRaC will provide the electromagnetic compatibility testing for medical devices and LRQA will provide conformity assessment services and CE certification under all device classifications.
With 20 years’ experience as a notified body, LRQA has established an in-depth level of knowledge and understanding of certification within the medical devices sector. So with our experience of quality management systems and CE marking, and TRaC’s EMC testing capabilities, we can help ensure that you meet your regulatory requirements.
Posted - October 2013