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