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The OpenRegulatory Blog. If you’re tired of regulatory stuff and just searching for entertainment, maybe our blog can be of service? :)

BEUDAMED: Better EUDAMED

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EUDAMED
September 22, 2024

The BfArM Processed Our Classification Request, And It Only Took 462 Days

Blog
June 12, 2024

You Want To Request Another Free Template? The Answer Is No.

Blog
June 11, 2024

We’re Collaborating With BerlinCert, a Software-Focused Notified Body

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Formwork
June 3, 2024

Where Using ChatGPT For Regulatory Documentation Will Fail

Blog
May 17, 2024

Launching Formwork Starter: 49€ For QMS Software And Requirements Management

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Formwork
April 18, 2024

The Emergence Of Premium Notified Bodies: 100k€+ For Certifications

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April 16, 2024

Unlocking Market Access: Navigating Reimbursement Challenges for Medical Device Startups in Europe

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Digital Health Business Strategy
April 11, 2024

How MDD Devices Die: Two Case Studies From The Real World

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February 19, 2024

We’re Making Medical Device Compliance 10x Cheaper

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October 24, 2023

Wise Business Is Great, Unless You Need Access To Your Money: Our Experience

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October 20, 2023

List of Controversial Auditor Opinions

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October 3, 2023

Before Our Call: Frequently Asked Questions

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June 7, 2023

Do We Need a Call?

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June 7, 2023

DiGAs and the Telekom Cloud Run On Chinese Software From Huawei. Say What?

Blog
May 24, 2023

Four Problems For DiGA Companies In The Future

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DiGA
Digital Health Business Strategy
May 24, 2023

Don’t Hire Senior Regulatory Affairs People

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May 24, 2023

We Got Audited By a Competent Authority. Here’s What You Need To Know.

Blog
November 11, 2022

We’re Sending Out Honest Rejections Now

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November 2, 2022

We’re Launching Free Consulting

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May 4, 2022

The Great Notified Body Survey

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February 25, 2022

No Cookie (Consent Dialogue) For You

Blog
January 2, 2021