Blog category
Medical Devices
Articles on Medical Devices from the Qualio blog.
Lola Furlong
A comprehensive guide to ISO 14971: Risk management for medical devices
Learn everything you need to know about ISO 14971, risk management for medical devices, and how to implement it into your quality management system.
Medical Devices
Ezra Kelderman
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.
Medical Devices
Ezra Kelderman
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.
Medical Devices
Robert Fenton
The 4 Best Medical Device Quality Assurance Training Options
Medical device quality assurance training can give your team the knowledge and confidence to move your company to the top of your industry.
Medical Devices
Ezra Kelderman
What is a Device History Record (DHR)? [Definition and Components]
Learn what Device History Record is and how is it used?
Medical Devices
Ezra Kelderman
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.
Medical Devices
Ezra Kelderman
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...
Medical Devices
Ezra Kelderman
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...
Medical Devices
Robert Fenton
How Long Does the FDA Medical Device Approval Process Take? [Timeline]
Learn more about the FDA medical device approval process timeline and how you can ensure that your company won't run out of money before you start...
Medical Devices