Active Medical Device Testing
TÜV SÜD Product Service, the EU’s largest medical device Notified Body, has extended its UK based medical device testing service to include electromedical safety testing in the UK.
This comes as a response to a surge in demand from UK customers who are preparing to align to the 3rd edition of the Medical Electrical Equipment Standard (IEC 60601-1:2005), in the lead up to the withdrawal of the second edition in June 2012.
"Implications of IEC 60601 3rd edition" Webinar
This new service has been designed to give manufacturers complete flexibility in how their products are tested. We can carry out safety testing either at manufacturer’s own facilities or in our state of the art laboratories. This flexible approach to testing with our existing EMC testing service and support from our compliance experts will help to decrease time to market for active medical devices while ensuring compliance and safety.
Our service includes:
- Conformity assessment against the relevant Medical Devices, Active Implantable Medical Devices or In Vitro Diagnostic Medical Devices Directives.
- Performing of laboratory tests (electrical safety, mechanical safety, performance tests, EMC, etc.) according to IEC 60601-1, IEC 60601-1-2 and selected part two standards.
- Assessment of safety-related issues.
- Assessment of the functional safety of active medical devices (safety of hardware and software
- Assessment of the usability of active medical devices
- Assessment of Risk Management files
Click HERE to download the EN 60601-1 3rd Edition Med-Info 
In addition to Active Medical Device Testing, TÜV SÜD Product Service provides a full range of testing, certification and training solutions with specific medical and health experience in:
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