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Medical Devices

Articles on Medical Devices from the Qualio blog.

Kelly Stanton

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

What are the regulatory expectations for software as a medical device (SaMD) startup companies? Learn which requirements SaMD companies...

Medical Devices
Ezra Kelderman

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...

Medical Devices
Kelly Stanton

3 Important FDA Medical Device Guidance Documents to Bookmark

What are the most important medical device guidance documents that your life science organization should bookmark? Start by...

Medical Devices
Ezra Kelderman

EU Medical Device Training: 4 Amazing Programs

What are the top EU medical device training programs this year? To start, we recommend...

Medical Devices
Kelly Stanton

4 Major Class II Medical Device Requirements

Looking for Class II medical device requirements? We've compiled the largest requirements that send many teams back to the drawing board...

Medical Devices
Sumatha Kondabolu

Understanding CAPA for medical devices: key concepts and requirements

Learn about CAPA for medical devices, explore examples, and understand the implementation process to ensure compliance and safety.

Medical Devices
Robert Fenton

Understanding Risk Classification of Medical Devices: 3 Major Grades

The FDA CDRH risk classification is based on the risk associated with your medical device. There are three risk classifications of medical devices including...

Medical Devices
Robert Fenton

The 5 Best Medical Device Product Lifecycle Management Tools

Let's look at the best medical device product lifecycle management (PLM) options to determine which will help you avoid big problems and...

Medical Devices
Robert Fenton

5 Essential Elements of a QMS for Medical Devices

Finding the right QMS system for medical devices can be a challenge. You need to prioritize these core elements including...

Medical Devices