Biocompatibility. Risk Standard. Usability Standard. 510(k). Electrical Safety. CE Mark. MDR. Notified Body. Exemption. SaMD. Exclusion. Conformity assessemnt. Technical file…
Stepping into the regulated world of medtech, the stream of bureaucratic ‘regulatory requirements’ generaly feels alternatively intimidating, boring or overwhelming to the entrepreneur with little or no experience in that field.
Regardless of the sentiment, there are two classic ways to deal with this inflow of redtape:
- ignoring it - deferring the problem to the next funding round where the entrepreneur can “hire someone” to somehow magically achieve all the promises from the pitch deck :)
- conscientiously trying to address each of these requirements in panic, in whatever order they come up in an email/Linkedin-post/webinar.
Neither work. You must build your regulatory strategy the same way you build your product: with purpose and agility. We are here to help you do that. Your strategy starts with you and your goals.
If you are more advanced already with your strategy, and knows what you want but need help to “put it together”, I can contribute to submission work in many different capabilities.
Contact me to arrange a chat.