Compliance becomes ever more important since regualtions change and are often amended. The focus must be on efficient compliance and transparent documentation. Keeping up with the frequent changes in this environment is a constant challenge for cost efficient solutions.

Safety and efficacy must be designed into the product. Be it a medical device or an in-vitro medical device. The design process goes hand in hand with risk managment - from the beginning. The new European regulations MDR and IVDR as well as US-FDA put a strict focus on adequate risk management and usability. My long experience in the field  will support you to pass all regulatory hurdles.

I am happy to supprt at the interfaces of production, logistics, and quality management. Start-up companies and restrucutring projects will profit from my experience in the area to make your investment a success.