All articles from Ezra Kelderman

A practical guide to implementing Risk Management for medical device startups

How SaMD companies can use a QMS to improve regulatory compliance

Software as a medical device: Definition, examples, and regulatory trends

Everything You Need to Know About Design Controls for Medical Devices

What is FDA Emergency Use Authorization

What is a Device History Record (DHR)? [Definition and Components]

What are the 6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations?

What is the Device Master Record (DMR)?

3 FDA Design Control Requirements for Medical Device Startups

What is the Global Unique Device Identification Database (GUDID)?

How to Get IEC 60601-1 Approval in 5 Easy Steps

EU Medical Device Training: 4 Amazing Programs

5 Major CAPA Medical Device Requirements

6 Things to Look for in a QMS Software for the Pharmaceutical Industry

The 5 Best Pharmaceutical Quality Systems Changing Life Sciences in 2022

FDA Regulatory Compliance Software?: Cloud vs. On-Premises [Explained]

14 Medical Device Quality Management System Requirements for Regulatory Compliance

Reviewing the Top Medical Device Quality Software Options for 2020

The Anatomy of a Healthy QMS for Life Sciences Companies