Validation of design, manufacturing processes and computer systems
Production and sterilisation processes
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.
Product design and packaging integrity
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.
Computer systems (CSV)
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.
Sebastian Weibel, Director of Production Engineering, Medela AG
“Thanks to the very competent support, the area of process validation has been significantly improved and has gained a high degree of effectiveness and efficiency. With the practical experience and the sound technical understanding, the support and coaching in the implementation was equally successful. At the same time it was never forgotten to involve the people, which led to a high level of acceptance."
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