The prototype is great! And now? inmedis assists 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. This includes the qualification and monitoring of cleanrooms as well as packaging an sterilisation processes of sterile medical devices.

inmedis supports you with MDR-compliant proof of the safety and performance of your medical device, including its packaging. We assist you in the planning of the verification and validation activities, in shelf life and transport simulations and in 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

• Quality of your products
• Patient safety
• Data Integrity

and thus, meet the requirements of ISO 13485: 2016.