For me, regulatory affairs and quality management are more than a means to gain market access.

 

It is true: registration is the prerequisite for market access. But the intention of regulation is not - as it sometimes seems - to make it particularly difficult for companies to introduce new medical devices. Rather, regulation aims to ensure that a safe and functioning product comes onto the market that effectively supports users and patients in the healing or treatment process. In turn, the manufacturers also benefit from this. With this understanding, regulation becomes a useful and meaningful tool for companies, society, users, and patients alike. It is important to me to convey this understanding to my customers and to anchor the necessary knowledge in the company. The logical consequence is that regulation takes time. In the best case, the subsequent approval of a product is already considered during its development. What takes longer at the beginning pays off at the end of the road with a speedy market launch. I would be happy to show you how you can implement this approach in your company.