From experts to experts.
We built this first to fit our own needs, and thought it should be helpful to others as well – so here we are.
Our background is in Medical Device industry for the last 14+ years in various roles from design, testing, quality and project management, supply chain management, risk management, and regulatory assurance. Products range go from wellness to active implants, from stand-alone SW to full-blown systems.
Wide range of projects, yet all similar in a couple of aspects…
Having spent countless hours with number of teams in various companies working on regulations and standards, it became evident that there are no sufficient tools for smooth work.
First, too much time is spent on reading these complex documents. Jumping around is frustrating, and it makes you loose big picture. It’s hard to find the implications that matter to you and your work.
Second, getting it right at first saves you from misery. In teamwork, it is of essence that everybody has the same interpretation and understanding of regulation :
What’s our interpretation on the clause, what are the implications to us, and how are going to comply?
Surprisingly often, this is still not crystal clear when you are supposed to be closing the project. Naturally, this compromises high quality results and risks the time to market. (It is often even hard enough to be consistent with our own personal interpretation of the standard or regulation from day to day! Or is it just me?)
All these add up time waste and risk regarding any compliance work
– be it product or process development, quality management, or planning your clinical evaluations –
or any other where you need to fulfill regulatory reguirements.
So, we tried to find a satisfactory tool for the purpose, unsuccessfully. Then the only way to get one was to build one. Soon, we started pilots with our dear customers in Germany, Finland and Sweden, and co-developed the service.
Now, we are proud to introduce our free trial of MDR (Medical Device Regulation EU 2017/745). It is still very basic, but we believe this is already making your work easier – and we’d love to hear your feedback to develop it to right direction.
Because here our work only begins. Our plans are to provide you smart tools in your regulatory work, and we shall soon provide you more documents and features.
Hope you find it useful!