IEC 60601-1 Pre-Compliance Evaluation for medical electrical devices
In order to comply with MDR requirements, medical electrical device (ME device) manufacturers must send their products to a certification test house and meet the many requirements laid out in IEC 60601-1. This is a costly and challenging process – it is exceedingly rare for a device to pass the requirements first time – often taking years of work and tens of thousands of pounds in costs.
At Test Labs, we offer an IEC 60601-1 pre-compliance evaluation service to help manufacturers avoid expensive repeat testing with a certification test house. Before you submit your device for compliance testing, Test Labs will perform a review of the associated documentation of a device (such as the risk file, markings, instructions for use (IFU), etc.), test the device for compatibility with the IFU using repeated cleaning, disinfection, and sterilisation cycles, and perform basic electrical, mechanical and temperature safety tests.
We can also perform optional tests, including an engineering file review (to IEC 60601-1-6 & IEC 62366), software life-cycle process review (to IEC 62304 & clause 14 of IEC 60601), and assess medical equipment used in the home healthcare environment according to the requirements of IEC 60601-1-11.
For manufacturers that also produce non-electrical medical devices, Test Labs also provides a reusable medical device reprocessing validation service.