If you’re anything higher than class I, you need a Notified Body to certify your software as a Medical Device.
What the Hell is a Notified Body?
They are privately held companies like TÜV SÜD, Dekra and BSI. Their task is to assess whether 1) your company has implemented an ISO 13485 - compliant Quality Management System (i.e., “is the company compliant?”) and 2) whether the Technical Documentation of your product is sound (i.e., “is the product safe?”).
In the US, this is done by a government-backed institution, the FDA. In Europe, you get to choose your Notified Body and have to pay them for everything. There certainly is some irony in that. In my understanding, that’s the definition of a conflict of interest, but for some reason I’m missing something obvious here. Because that’s how Medical Devices get certified in Europe.
Which One Should You Choose?
Notified Bodies differ in their strictness and in their pricing. As a startup, your priority should be to get through the audit with minimum effort while ensuring that your software is safe for users. That being said, I wouldn’t recommend Notified Bodies which are known for their strictness - nobody earns brownie points (or money) for superb regulatory compliance.
This is about shipping products which help patients and enable a company to become profitable.
Other important things to keep in mind:
- How well do they understand software? Do they have software experts on their team or is it just a bunch of dudes who certified some hardware which was connected to software? Always prefer software experts.
- How friendly are they? Do they strictly adhere to rules or understand that startups are often struggling to fulfil all regulatory requirements?
- How soon can they audit you? Many Notified Bodies have crazy long waiting lists.
- How good is their customer service? You’ll be in touch with them regularly when you make changes to your product. You don’t want to be waiting for unresponsive customer managers before deploying a new version.
Message me for further insights :)