Akina, a startup focusing on Physiotherapy, passed their MDR QMS audit only 6 months after starting with Formwork:| OpenRegulatory
The Wizard| OpenRegulatory
How long does it take to get medical device compliance done? Check out the three most important things you have to get right a startup.| OpenRegulatory
Mistake #1| OpenRegulatory
The EU MDR is enforced very subjectively when it comes to MDR class I software. We've collected some examples.| OpenRegulatory
Alright! Now the MDR is here and nobody really has any clue on how to classify software. Well, we consultants typically pretend to understand it but the truth is, if you ask multiple consultants, you just get lots of different answers (and bills). But now the MDCG has released a guidance document on MDR medical device classification […]| OpenRegulatory
The complete walkthrough: MDR class I example devices, where to found your company (not in Berlin!), how much it costs and how long it takes.| OpenRegulatory