The prototype is great! And now? inmedis assist you with the design transfer of your medical device. Our experts will be with you all the way from the validation planning through the qualifications (DQ / IQ / OQ / PQ) to the release of your validated processes for series production.
inmedis support you with MDR-compliant proof of the safety and performance of your medical device. We accompany you from the planning of the verification and validation activities to the final documentation of the results. That way your customers, as well as the authorities, will be convinced of the safety and effectiveness of your product.
Do you trust your business software? Software validation does not have to be a bottomless pit. Through our risk-based approach according to GAMP 5, we can focus the validation on the truly relevant software functions. We assess your business software for its impact on the
and thus, meet the requirements of ISO 13485: 2016.