Notified Body Capacity and Reviews

Choosing a notified body is hard because you can’t find any reviews by past customers.
Let’s change that! We’re collecting anonymous reviews by other companies here and publishing them openly, for free.
That enables you to choose a notified body which actually understands software and replies to emails (yes, the bar is that low).

New: Notified Body Capacities (a.k.a. the MDR fiasco)

As an increasing number of Notified Bodies have started to decline accepting new customers, we’ve added indicators below to reflect their capacity.

Important Notes on Reviews

While we’ve gathered quite a lot of reviews spanning multiple notified bodies, we don’t have a whole lot of reviews for each notified body. That’s why we decided not to calculate an average rating for each notified body – for now.
Also, notified bodies typically work with many different auditors, some of which are freelancers. That’s one of many reasons which may lead to strongly varying reviews of the same notified body.

And lastly: Even though some reviews may be negative, the goal is not to rant about notified bodies. We’ve built this to facilitate the sharing of information between Healthcare companies. The goal is to improve Healthcare by helping everyone bring medical devices to market in a safe, predictable, affordable and fair way.

As manufacturers get to choose their notified body, these reviews should help companies choose one which is fair, well-organized and technically competent.
Green means they’re scheduling audits in a reasonable time frame, yellow shows an unreasonable time frame (many months), red means they don’t accept new customers and dark red means they don’t even respond to emails.
We don’t have capacity data on all Notified Bodies. So please message us if you know more! 🙂