Qualio Blog: Quality & Compliance Hub » medical devices
Categories
Aug 31, 2021 • 4 min read
Medical Devices

What is a Device History Record (DHR)?

By Ezra Kelderman
Aug 19, 2021 • 6 min read
Medical Devices

6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations

By Ezra Kelderman
Aug 17, 2021 • 4 min read
Medical Devices

What is the Device Master Record (DMR)?

By Ezra Kelderman
Aug 10, 2021 • 5 min read
Medical Devices

3 FDA Design Control Requirements for Medical Device Startups

By Ezra Kelderman
Aug 03, 2021 • 5 min read
Medical Devices

What Is the Unique Device Identification (UDI) System and Why Is it Important?

By Kelly Stanton
Jul 27, 2021 • 6 min read
Medical Devices, FDA

How Long Does the FDA Medical Device Approval Process Take?

By Robert Fenton
Jul 15, 2021 • 5 min read
Medical Devices

Regulatory Expectations for Software as a Medical Device (SaMD) Startups

By Kelly Stanton
Jul 13, 2021 • 4 min read
Medical Devices

What is the Global Unique Device Identification Database (GUDID)?

By Ezra Kelderman
Jul 06, 2021 • 5 min read
Medical Devices

How to Get IEC 60601-1 Approval in 5 Easy Steps

By Ezra Kelderman
All posts