In May 2015, René Roncken and Robin Lucchesi decided to found the company to be able to provide services to the medical device industry in the process for obtaining and maintaining CE-mark for medical devices or market access in the European Union. With broad knowledge and insight into the process of medical device development, the process for confirmation of compliance with the regulations and guidelines as well as the continuous post market surveillance, the synergy between the company management, employees and associates has been successful in providing the medical device companies tailor made support on the often-difficult challenges.
Part of the success is the available network of associates and freelancers with whom we have worked and continue to be working with for the upcoming years. With the broadening of the challenges from design and development of a medical device, compliance with the regulatory requirements, looking ahead for the data to be collected in the verification and validation phase as well as market strategy and changing environments require input from many angles and expertise.
Keeping oversight and remaining critical at each step taken and to be taken to obtain market access is nowadays a must as market access has become a more detailed puzzle where the pieces need to be all in place at the end.
As such, now 10 years later, at times it still feels like we are at the beginning due to the ever-changing regulations, however, we are equally enthusiastic and interested in finding solutions to the questions and challenges that the medical device companies encounter.
We are looking forwards to the next 10 years in serving the medical device industry in providing solutions and guidance to their questions and challenges.