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Read our articles for step-by-step guides on how to get your medical device compliance done. Select a topic on the right side to filter the articles by topic.

MDR UDI: What It Is And How To Get It At GS1 Or IFA

Getting Started
UDI
Walkthrough
June 13, 2024

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

Blog
June 12, 2024

MDR Class I: Everything You Need To Know

Getting Started
MDR Class I
Walkthrough
June 12, 2024

One of those Bugs a Software Engineer lives for

Engineering
June 12, 2024

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

Blog
June 11, 2024

IVDR Classification: Classification Of In-Vitro Diagnostic Devices

IVDR Compliance
June 7, 2024

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

Blog
Formwork
June 3, 2024

Software Validation: How To Do It (Pain From Hell)

Quality Management
Software Validation
May 25, 2024

Qualio Price: What We Know So Far

QMS Software
Qualio
May 23, 2024

Greenlight Guru Price: Beware Of Lock-In!

QMS Software
Greenlight Guru
May 23, 2024

Qualio Alternative: Don’t Make This Mistake

QMS Software
Qualio
May 19, 2024

Greenlight Guru Alternative

QMS Software
Greenlight Guru
May 19, 2024

IEC 62304 PDF Download

Random
Accessing Standards
May 18, 2024

IEC 62366 PDF Download

Random
Accessing Standards
May 18, 2024

ISO 14971 PDF Download

Random
Accessing Standards
May 17, 2024

ISO 13485 PDF Download

Random
Accessing Standards
May 17, 2024

Where Using ChatGPT For Regulatory Documentation Will Fail

Blog
May 17, 2024

Doing The Literature Review For Clinical Evaluation Reports for Software as a Medical Device

Clinical Evaluation
May 14, 2024

FDA Risk Classification for Software as a Medical Device (SaMD)

FDA Compliance
May 14, 2024

All You Need to Know About QMS Software

QMS Software
May 8, 2024

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

Blog
Formwork
April 18, 2024

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

Blog
April 16, 2024

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

Blog
Digital Health Business Strategy
April 11, 2024

MDR Post-Market Surveillance: The Ultimate Guide

Quality Management
ISO 13485
April 11, 2024

QMS Software for Medical Devices (ISO 13485): Comparison

QMS Software
April 4, 2024

The True Shadiness Of QMS Software For Medical Devices

QMS Software
Rant
April 4, 2024

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

Blog
February 19, 2024

No, Telemedicine Software Is Not Class IIa Under The MDR

Regulatory News
MDR Class I
MDR Classification
January 25, 2024

Free QMS Software: Google Drive, SharePoint, GitHub, GitLab

QMS Software
GitHub QMS
GitLab QMS
Nextcloud QMS
Redmine QMS
November 23, 2023

ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes

Quality Management
ISO 13485
November 15, 2023

We’re Making Medical Device Compliance 10x Cheaper

Blog
October 24, 2023

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

Blog
October 20, 2023

MDR Classification: Examples for EU MDR Devices

Technical Documentation
Medical Device Classification
October 18, 2023

List of Controversial Auditor Opinions

Blog
October 3, 2023

IFA UDI Hack: Save Money By Using a Health Product Code (HPC)

Technical Documentation
UDI
August 21, 2023

Brace for Impact: The New MDR Transition Periods

Regulatory News
August 15, 2023

Time Zones in Rails

Engineering
August 10, 2023

Automating Medical Device Compliance With QMS Software: Can you eQMS the pain away?

QMS Software
Formwork
August 1, 2023

Clinical Evaluation

Uncategorized
July 26, 2023

July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software

Regulatory News
July 21, 2023

Open Source QMS Software Overview: GitLab As QMS?

QMS Software
GitHub QMS
GitLab QMS
July 19, 2023

Supplier Management Under ISO 13485:2016

Quality Management
July 11, 2023

Maybe Harmonized Standards Are Becoming Freely Available Soon

Regulatory News
Accessing Standards
July 7, 2023

How To Do a Summative Usability Evaluation For IEC 62366 Compliance

Technical Documentation
IEC 62366
July 7, 2023

The IEC 62366 (Usability) Summary: All You Need To Know (It’s Not Much)

Technical Documentation
IEC 62366
July 7, 2023

MDD Class I: Here’s What You Have to Do Before May 2021

Getting Started
June 22, 2023

People You Need: Person Responsible for Regulatory Compliance and Medical Device Consultants

Getting Started
June 22, 2023

Do We Need a Call?

Blog
June 7, 2023

Before Our Call: Frequently Asked Questions

Blog
June 7, 2023

How We Keep Your Formwork Data Safe

QMS Software
Formwork
May 31, 2023

Is Formwork an Enterprise Software? Does It Have [Enterprise Feature X]?

QMS Software
Formwork
May 31, 2023

Setting Up a Quality Management System (QMS) in Google Drive

QMS Software
Google Drive QMS
May 24, 2023

GitHub QMS: We No Longer Recommend It

QMS Software
GitHub QMS
GitLab QMS
May 24, 2023

Clinical Evaluation: How to Write a Regulatory Compliant Literature Review

Clinical Evaluation
May 24, 2023

Enterprise QMS Software: Don’t Waste Your Money

QMS Software
Formwork
May 24, 2023

Medical Device Translations: 3 Steps For Translating Software as a Medical Device

Technical Documentation
May 24, 2023

What Is QMS Software, and Do You Need It?

QMS Software
May 24, 2023

How to Get a UDI (Unique Device Identifier) For MDR Compliance

Technical Documentation
UDI
May 24, 2023

FMEA, Part 1: Risk Acceptance Matrix (ISO 14971 Risk Analysis)

Technical Documentation
ISO 14971
May 24, 2023

ISO 14971 Walkthrough

Technical Documentation
ISO 14971
May 24, 2023

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

Blog
May 24, 2023

Clinical Evaluation Report (CER) For Medical Devices: 3 Easy Steps

Clinical Evaluation
May 24, 2023

Doing a Software Release in Compliance With IEC 62304

Technical Documentation
IEC 62304
May 24, 2023

Software System Testing Based on the IEC 62304

Technical Documentation
IEC 62304
May 24, 2023

Medical Device Software Architecture Documentation (IEC 62304)

Technical Documentation
IEC 62304
May 24, 2023

Software Verification For Medical Device Software (IEC 62304)

Technical Documentation
IEC 62304
May 24, 2023

Writing An Intended Use for Software as a Medical Device

Getting Started
May 24, 2023

100.000€ Spent and Never Done (Fail)

Case Studies
May 24, 2023

Setting Up a Quality Management System (QMS) in GitHub / GitLab

QMS Software
GitHub QMS
GitLab QMS
May 24, 2023

Writing Software Requirements Based on the IEC 62304

Technical Documentation
IEC 62304
May 24, 2023

Medical Device Classification

Getting Started
May 24, 2023

How to Classify Software as a Medical Device Under the MDR? (MDCG 2021-24)

Getting Started
May 24, 2023

Choosing a Notified Body

Getting Started
May 24, 2023

Getting The ISO 13485 And Other Standards For Less Than 30€

Getting Started
Accessing Standards
Walkthrough
May 24, 2023

Writing Technical Documentation

Technical Documentation
May 24, 2023

Writing a Software Development and Maintenance Plan for IEC 62304 Compliance

Technical Documentation
IEC 62304
May 24, 2023

Four Problems For DiGA Companies In The Future

Blog
DiGA
Digital Health Business Strategy
May 24, 2023

Don’t Hire Senior Regulatory Affairs People

Blog
May 24, 2023

IEC 62304 Walkthrough

Technical Documentation
IEC 62304
May 24, 2023

CAPA (Corrective and Preventive Action): What Is It and How To Be Compliant?

Quality Management
ISO 13485
May 23, 2023

The MDR Class I Software Situation

Getting Started
MDR Class I
May 23, 2023

IEC 62366

Uncategorized
November 22, 2022

ISO 14971

Uncategorized
November 22, 2022

IEC 62304

Uncategorized
November 22, 2022

ISO 13485

Uncategorized
November 22, 2022

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

Blog
November 2, 2022

Generate Your Technical Documentation Automatically: Formwork Audit Export

QMS Software
Formwork
August 28, 2022

Using Formwork as a Regulatory Consultant

QMS Software
Formwork
July 7, 2022

Copying Records is Tedious.. Not Anymore!

QMS Software
Formwork
July 7, 2022

No Lock-In, Ever: Formwork Batch Export

QMS Software
Formwork
June 26, 2022

We’re Launching Free Consulting

Blog
May 4, 2022

The Great Notified Body Survey

Blog
February 25, 2022

The IVDR Might Require 264 Notified Bodies

Regulatory News
January 17, 2022

ISO 13485 Amendment, Templates, User Manuals

Regulatory News
December 17, 2021

MDR Classification Chaos and User Manuals

Regulatory News
December 7, 2021

FBE GmbH: Solving Problems and Reviewing Documents For Less Than 2.000€

Case Studies
November 10, 2021

OpenRegulatory Newsletter #1: Conference

Regulatory News
September 12, 2021

Exakt Health: MDD Class I Compliant in 3 Months

Case Studies
August 11, 2021

No Cookie (Consent Dialogue) For You

Blog
January 2, 2021

MDR Compliance: The Blueprint for Certifying Medical Software

Getting Started
Walkthrough
June 17, 2020