Blogs

March 6, 2025

IEC 62304: Software development, the medical device version

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February 26, 2025

Process validation 101: Why your medical device needs to work (every single time)

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December 18, 2024

FormlyAI and QbD Group Join Forces to Revolutionize Lifescience Technical Documentation

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October 25, 2024

9 Common Misconceptions About Medical Device Regulations 

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September 26, 2024

Big news - introducing our new eQMS and improved pricing

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August 12, 2024

What Happens When Your Medical Device has an Issue - The CAPA Process

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July 17, 2024

Struggling to find funding to CE mark your medical device? These grants can help.

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June 18, 2024

The AI Act: What does this mean really for your medical device?

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May 20, 2024

The unique device identifier (UDI) aka the barcode for EU medical devices. Do you need one?

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May 6, 2024

How to Keep Your Medical Device on the Market With Post-Market Surveillance

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March 28, 2024

How To Choose The Right Notified Body 

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March 5, 2024

What is Software of Unknown Provenance (SOUP)?

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February 13, 2024

Can I Certify as Class I First and Do Class IIA Later? 

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February 8, 2024

The Difference Between IVDR and MDR in the EU

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January 31, 2024

Am I a Medical Device? A Strategic Guide on EU Medical Device Classification

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February 5, 2024

Navigating CE Marking for Medical Devices: A Cost-Effective Roadmap for Startups

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January 10, 2024

Announcing Our Closed Beta Program for CE Marking

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July 2, 2023

What is a medical device technical file and why is it important?

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April 28, 2023

What is a quality management system (QMS)? A basic guide to ISO 13485.

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April 28, 2023

Who Is Formly

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Medical Device Certification Made Easy.