Medical Devices
What you need to know about medical device validation
Medical device validation determines whether you built the right product for its intended use. Learn the benefits and key steps of medical device validation.
Medical device quality management system template: 8 powerful options
With the right medical device quality management system template, you can quickly produce a market-leading device. Use these 8 templates to get started.
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.
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.
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.
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.
![What is a Device History Record (DHR)? [Definition and Components]](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2Fpy379f3b%2Fproduction%2Fbdb726b8b8e7b176837a0d8be6563d491f787c26-1200x628.jpg%3Frect%3D98%2C0%2C1005%2C628%26w%3D600%26h%3D375&w=3840&q=75)
What is a Device History Record (DHR)? [Definition and Components]
Learn what Device History Record is and how is it used?
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.
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...
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...