Regulatory Affairs solutions to access the European Market
Medical Devices
Invest your time and efforts on running your business and benefit from our experience to win the race for compliance.
What we do
#1
Regulatory consulting
Regardless of whether this is about medical device development, technical documentation or clinical studies, we, at SfMEDEV, are committed to help you meeting regulatory targets while you are achieving your business goals.
Our detailed knowledge gathered over years while working with Class III medical devices (implants) ensures that your needs will be identified rapidly and adressed in time according to your deadlines.
#2
documentation management
One of the key change in the EU’s medical device regulation (MDR) is about a more stringent documentation. Based on that, any missing information or simply difficult to locate will seriously delay conformity assessments by the authorities.
In response, we have check lists we are happy to share and/or train your company team members as well as documentation management systems we can recommend and help setting up depending on your business.
#3
CE Marking
To access the European market, one must first assess your medical device’s class. It is highly recommended to do it with a notified body to avoid bad surprises later on. We can represent you before those authorities or provide advice according to your needs.
Thereafter, conformity assessment procedures, technical files reviews, clinical evaluation reports and audits are part of our offer to guide you towards successful certification.