Blogs

October 25, 2024

9 Common Misconceptions About Medical Device Regulations

September 26, 2024

Big news - introducing our new eQMS and improved pricing

August 12, 2024

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

July 17, 2024

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

June 18, 2024

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

May 20, 2024

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

May 6, 2024

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

March 28, 2024

How To Choose The Right Notified Body

March 5, 2024

What is Software of Unknown Provenance (SOUP)?

February 13, 2024

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

February 8, 2024

The Difference Between IVDR and MDR in the EU

January 31, 2024

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

February 5, 2024

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

January 10, 2024

Announcing Our Closed Beta Program for CE Marking

July 2, 2023

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

April 28, 2023

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

April 28, 2023

Who Is Formly

September 10, 2022

US vs EU Medical Device Regulations: What is the difference?