Your Situation

You've brought your Medical Device to market. Yay!

But now, your life is a living hell: Software releases take forever and are plastered with approval steps. Signing documents requires you to jump through multiple hoops. Your best software engineers have left in frustration while the remaining ones are fighting with your regulatory department every day.

You tell yourself: I'm never working in Healthcare again!

Here's what we typically tell companies at this stage:

You're probably looking for a silver bullet - like a tool to automate your compliance. Sure, that might help.

But, in our experience, this is more a situation of death by a thousand paper cuts. There is no easy fix. Now, we all have to sit down and fix one problem after another.

We'll get together and look through your processes and documentation. Where can things be made more efficient? Does every document need to be signed by 10 people? Can't you use more modern tools for auto-generating some of your documentation?

This is not our first time.

We've worked with over 40 companies. Here are some.

ISO 13485 Audit Passed

Oliver was brought in to help Ada Health in certifying their Quality Management System based on ISO 13485. They successfully passed the audit by a Notified Body in June 2020.

MDD Class I Device Shipped

Exakt Health set its goal to ship its innovative, physiotherapy-at-home app before the MDD deadline in May 2021. We helped Philip, their CEO, achieve this goal and bring their app to market as a medical device - before the deadline.

MDD Class IIb Device Certified

Vara was Sven's and Oliver's past startup which developed a machine learning - based software for breast cancer screening. Together with the team, we passed the ISO 13485 audit and got the product certified as class IIb medical device under MDD.

What Will We Do?

We'll get together for multiple days to figure out how we can fix this.

What does that mean? I don't know. Your situation is complex.

Possible solutions could be: Simplifying processes, reducing required documentation effort and using modern tools to automate stuff.

And don't forget: Due to our audit experience, we have a pretty good feeling for how much documentation is enough documentation.

How do other consultants do it?

They will probably do the same.

They might be slower and less pragmatic, though.

How Much Does It Cost?

1.440€ per day per consultant.

How do other consultants do it?

They usually charge more.

Ready to get started?

Send us an email or schedule a call - it's free!

Frequently Asked Questions

Do you have experience with large enterprises in similar situations?

Yes.

Is there a silver bullet?

No.

How did we get into this situation?

My best guess is that your company has a culture in which people weren't incentiviced or empowered to reduce regulatory complexity. That's understandable, because reducing compliance work always carries the risk of becoming non-compliant.

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