All articles from Ezra Kelderman
Medical Devices
A practical guide to implementing Risk Management for medical device startups
Medical Devices
How SaMD companies can use a QMS to improve regulatory compliance
SaMD
Software as a medical device: Definition, examples, and regulatory trends
Medical Devices
Everything You Need to Know About Design Controls for Medical Devices
Medical Devices
What is a Device History Record (DHR)? [Definition and Components]
Medical Devices
What are the 6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations?
Medical Devices
3 FDA Design Control Requirements for Medical Device Startups
Medical Devices
What is the Global Unique Device Identification Database (GUDID)?
Paper-Based
6 Things to Look for in a QMS Software for the Pharmaceutical Industry
Quality Systems
The 5 Best Pharmaceutical Quality Systems Changing Life Sciences in 2022
Paper-Based
FDA Regulatory Compliance Software?: Cloud vs. On-Premises [Explained]
Medical Devices
14 Medical Device Quality Management System Requirements for Regulatory Compliance
Medical Devices
Reviewing the Top Medical Device Quality Software Options for 2020
Ezra Kelderman
Ezra, Quality Engineering Manager, brings nearly 10 years of quality experience to his role at Qualio. He’s led teams across the industry through FDA compliance journeys, rigorous audits and cloud-based QMS builds.