Early access registrations are open for Headstart, a predictable, fixed-price program for becoming compliant.

How can you solve it?

Option A

Teach yourself

Teach yourself how to certify your software by reading all articles here.

You'll need one person working on this full-time for a few months. It's perfectly doable. This is how I did it the first time.

If you have questions, feel free to send me a short email and I'll answer them for free!

Here's the first post to get you started:

Option B

Let me help you, a bit

Do it yourself, but I'll help you along the way. I can save you quite time and effort by preventing you from going down rabbit holes and creating unnecessary processes and documentation.

You'll still need someone working on this full-time internally. I'll work closely with that person.

While I answer emails for free (see Option A), this will take multiple days at least. Regulatory consulting isn't very fun for me, so you'll have to pay me by the hour.

Option C

All-in-one package

Get everything done by me.

This won't save you from having to understand everything though: In the end, you will have to maintain your own regulatory documentation - or do you plan to pay me forever?

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No QMS on this planet will save you from creating crappy software.