There are two types of approaches to regulatory affairs and device compliance. The first approach is what was causing Ed so much stress. Where device compliance is an afterthought, a series of bureaucratic hoops to jump through, an anchor wrapped around the budget of big companies who need to ‘cut costs this quarter’.
The second approach is one of thought and precision. It takes a special kind of person to see the true art and benefits to medical writing. A dedication to getting the details right is vital, but above all else one must actually care.
So, you came to this page to see what our company was about? Well, It’s pretty simple.
We care about producing documents that matter for your devices. Whether it’s a CER, or a systematic literature review to shore up your EU MDR Technical file, we are on a never-ending quest to find the perfect process, the most dedicated and well-trained staff, the most state-of-the art software tools.
If you came looking for a chop shop with an army of faceless contractors, then I’m sorry but that’s not our thing.
If you’re looking for a partner who’s not afraid to get into the trenches with you and do the hard work, but also has the seasoned experience to advise and direct…then we should talk.