For medical device registration in a national reimbursement system, certain test certificates have to be submitted. These requirements are not necessarily covered in the Medical Device Act 93/42/EEC or are not sufficient.
Depending on product type and its respective classification, the applicable test standards have to be identified. Subsequently, manufacturers need to find the right testing laboratories which can conduct the tests or, in certain cases, are also accredited.
Due to so many different country-specific requirements, it is difficult to keep an overview and to determine the product-relevant tests. BEO BERLIN® is familiar with these respective requirements, can research the right testing laboratory and can co-ordinate the testing up to a successful test report.