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.
Articles by Ezra Kelderman
Medical Devices
A practical guide to implementing Risk Management for medical device startups
Follow this step-by-step approach to implementing risk management in your medical device startup and review what's essential in effective risk management.
Ezra KeldermanJun 9, 2022
Medical Devices
How SaMD companies can use a QMS to improve regulatory compliance
Without understanding regulatory expectations for software as a medical device (SaMD), an SaMD company may fail to meet FDA requirements. Learn how a QMS can help.
Ezra KeldermanMay 11, 2022
Medical Devices
What is a Device History Record (DHR)? [Definition and Components]
Learn what Device History Record is and how is it used?
Ezra KeldermanAug 31, 2021
Medical Devices
What are the 6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations?
Wondering what's involved in producing a Clinical Evaluation Report for medical device organizations? Learn what the essentials are so you can accurately allocate resources to complete a medical device Clinical Evaluation Report.
Ezra KeldermanAug 19, 2021
Medical Devices
What is the Device Master Record (DMR)?
What is the Device Master Record and how is it used? We'll explain how to utilize DMRs for medical device safety and compliance...
Ezra KeldermanAug 17, 2021
Medical Devices
3 FDA Design Control Requirements for Medical Device Startups
What are the most vital medical device design input requirements to be aware of? The FDA design control system can help your organization...
Ezra KeldermanAug 10, 2021
Medical Devices
How to Get IEC 60601-1 Approval in 5 Easy Steps
Use our guide to obtain IEC 60601-1 approval for your medical device by controlling for safety and performance requirements in 5 easy steps...
Ezra KeldermanJul 6, 2021
Medical Devices
EU Medical Device Training: 4 Amazing Programs
What are the top EU medical device training programs this year? To start, we recommend...
Ezra KeldermanMay 18, 2021
Paper-Based
FDA Regulatory Compliance Software?: Cloud vs. On-Premises [Explained]
Should you use a cloud-based FDA regulatory compliance software or host your solution on-premise?
Ezra KeldermanMay 15, 2020