Question 1

What is medical device certification and why is it important for my business?

Accepted Answer

In the EU, medical device certification is a CE mark, indicating that the product meets EU safety, health, and environmental protection requirements. In the US, it means approval by the FDA, ranging from registration for Class I devices to 510(k) clearance for Class II devices or PMA for Class III devices.

Question 2

What is the certification process for medical devices?

Accepted Answer

The certification process involves determining product risk class, establishing a Quality Management System (QMS), creating technical documentation, undergoing an audit (if required), and maintaining post-market requirements.

Question 3

What are the regulatory requirements for certification and does FormlyAI cover them for my device?

Accepted Answer

Formly covers all standards required to meet US and EU market requirements, including EU MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62366, and IEC 62304.

Question 4

I don't know anything about medical device regulations. Is Formly right for me?

Accepted Answer

To be verified

Question 5

When should I start to work on certification? Can I start too early on this?

Accepted Answer

You can’t be too early but you can be late. Once you understand what product you want to build, you can start your certification journey.

Question 6

Can my product be Class I now and then be Class IIA (or Class II) later?

Accepted Answer

Yes. See more in our blog post on the subject.

Question 7

How long does it take to get my medical device certification?

Accepted Answer

This depends on the medical device class. Class I software medical devices can take days to months, Class II (IIa / IIb) medical devices can take months to years, and Class III devices take multiple years.

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