By applying harmonized standards, you can show that your medical device complies with the relevant safety and performance requirements.

Your need to pay particular attention to the oft-neglected downstream processes of transport, storage, updating, servicing, maintenance, repair, decommissioning and disposal processes for your medical device in development and production.

It is vital to be familiar with all necessary and applicable regulatory requirements of your medical device early in the development phase. One of your most important tasks is to define your target markets and the corresponding registration or approval strategy.

In my professional life I have gathered detailed theoretical and practical knowledge and experience in regard to the lifecycle of medical devices. I would be happy to share my knowledge with you in order to bring your medical device successfully to market.