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The Qualio Blog
Insights on product development, quality management, and regulatory compliance for teams building life-saving products.
Robert Fenton
5 Essential Elements of Quality Management Software
Not all quality management software is created equal. These are the five essential elements that...
eQMS
Robert Fenton
Improving Healthcare Access for Vulnerable Populations
Starting this year, Qualio will donate 1% of our annual revenue to improving healthcare access for vulnerable populations.
Updates
Robert Fenton
From Hippie to Med School to Entrepreneur with Dr. Hana, MD
Dr. Hana Solomon, MD shares her journey from hippie to single-mother to med school to entrepreneur. She's the founder of BeWell Health and inventor of Nasopure, the most comfortable nose wash in the world. She shares her wisdom to avoid "stupid business mistakes" such as acquiring the right type of
Podcast
Robert Fenton
Does an FDA Class 1 Medical Device List Exist?
Learn about the pathway to approval if your product can be classified as a Class 1 medical device.
Compliance
Robert Fenton
What Are the Objectives [5 Examples] of Quality Assurance in the Pharmaceutical Industry?
Learn about the 5 critical objectives of quality assurance in the pharmaceutical industry. If you don't want to fall behind the competition, you need to ensure...
Quality Systems
Robert Fenton
FDA to Issue New Guidance on QMS Validation: 4 Major Changes
The FDA plans to issue new guidance on QMS validation. Here are some of the changes that we...
FDA
Robert Fenton
5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make
IEC 63204 compliance is a functional safety standard that applies to medical device development and maintenance. We've found that most...
Compliance
Robert Fenton
The ISO 13485 Checklist for Medical Device Manufacturers
Are you preparing for ISO 13485 certification? Consult this helpful ISO 13485 checklist so that you can streamline certification and...
ISO 13485
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