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The Qualio Blog

Insights on product development, quality management, and regulatory compliance for teams building life-saving products.

Robert Fenton

Rapidly Discovering and Extracting Natural Pharmaceuticals

Mental health issues have been on the minds of many as athletes are under tremendous pressure to perform perfectly at the Olympics.

Podcast
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
Kelly Stanton

Identifying the 4 Most Common Problems With Your CAPA Process

What are the most common problems that occur within CAPA processes? Learn how to identify issues before they start and how to avoid them...

eQMS
Kelly Stanton

5 Major Total Quality Management Principles for Medical Device Startups

What are the most vital total quality management principles for medical device startups to follow? Learn how successful new medical startups...

eQMS
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
Kelly Stanton

What's the Difference Between Biopharmaceutical vs. Pharmaceutical Startups?

What are the key differences between biopharmaceutical and pharmaceutical startups? Biopharma and traditional pharma startups both share...

Pharmaceutical
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
Louis Suchy

Qualio now offers industry-leading high availability

We made Qualio a high available product to help life science companies bring products to market faster.

Updates
Robert Fenton

Launching the First Single-use Endoscope for Unsedated Pediatric Endoscopy with Dr. Heather Underwood, CEO of EvoEndo

Today’s guest on the podcast is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated single-use endoscope to market.

Podcast