This is the first letter of what I hope will be a long and fruitful correspondence.
As we both know, the regulatory landscape for medical devices in Europe is complex and complicated and you, the Manufacturer, or the Medical Writer, or the Regulatory Professional, or the Academic looking to turn Entrepreneur may find it difficult to find your way sometimes. We have all been there. The uncertain times we are currently traversing worldwide do not make it any easier and you may, occasionally, feel confused or at a loss, unsure of what the next best step in your project would be. But, as with most other human endeavours, communication is the key starting point to overcoming whatever hurdles we are dealing with.
I have been navigating what may sometimes seem like the maze of MDR regulatory requirements for about 8 years now. It is a continuous process of learning new things, adapting to new standards, diving deep into a clinical area I may have been unfamiliar with before, understanding a new device that brings a different approach to tackling some clinical problem, making sense of the nuances of some specific wording in some paragraph of a guideline document. During this time, I have found that talking to people in the industry, irrespective of their role, be it on the regulatory, engineering, clinical, patient advocacy or communication side of things, always shines a light on something, helps connect dots and brings about an ever-clearer picture of the medical devices space. It is also a good reminder that, no matter how much AI we may incorporate into our lives, we are, at the end of the day, humans and we find comfort in voicing our questions and concerns to other humans who may understand and even empathize.
This realization is what gave me the idea for these letters. Once a week, I aim to write to you, the Manufacturer, the Entrepreneur, the Medical Writer, the Academic, the Regulatory Professional about a medical devices topic that has been on my mind, share a perspective, share some thoughts and questions. My hope is that you will find these letters useful and enjoyable and that you may, in time, write back.