As a medical device manufacturer and as a medical device startup, your responsibilities don’t end when your orthopedic or other medical device product innovation launches on the market. In the EU for example, you must keep an eye on the product for as long as it is on the market according to various (MDR) regulations.
You have a great innovation for a medical device. Now, what are the first steps to take apart from getting investors on board and raise funding? Think about realising post market surveillance (PMCF) from the project start and the feasibility of commercial succes greatly improves. BAAT has the experience and know-how to manage and service all requirements that medical startups encounter. This includes the manufacturing route, CE/FDA application but PMCF as well. You focus on marketing and sales (and getting investors on board) and let us take away the pains that come with ensuring traceability of medical device innovations. Get ready for launch without headaches and hurdles that will come your way. Read all about do’s and don’ts concerning (post) market surveillance and feel free to contact us to get more info on how to move your project forward sustainably.