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

Jerry Adatsi

What is an ICH Q10 pharmaceutical quality system?

What is an ICH Q10 pharmaceutical quality system? It's your company's key to safe, effective and continuously improving products. Learn more with our breakdown guide.

ICH
Robert Fenton

ISO 13485 vs. ISO 9001: understanding the key differences for medical devices

Discover the key differences in scope, significance and application between the ISO 13485 and ISO 9001 quality standards for medical devices.

Medical Devices
Lola Furlong

5 notorious compliance issues in the pharmaceutical industry

Ensure you don't receive an FDA 483 warning letter. Discover the most common compliance issues in the pharmaceutical industry and review your quality system.

Compliance
Sumatha Kondabolu

510(k) submission checklist to get your medical device to market

A 510(k) submission checklist is a crucial tool for a controlled, confident and successful premarket notification. Get yours now!

510(k)
Qualio supports 1% For All Life
Robert Fenton

Qualio donates 1% of revenue to charity for a third consecutive year

Qualio donates 1% of our annual revenue to improving healthcare access for vulnerable populations for the 2nd year in a row.

Company news
Robert Fenton

5 tips for quality management compliance

Worried about your quality and compliance? We show you how to ensure your quality management system is tip-top, compliant and audit-ready.

Quality management
Qualio document editor in suggesting mode with tracked changes and comments
Alex Pavlović

We just launched the best native document editor on the eQMS market

Real-time collaboration, a new toolbar, fresh features and more! Our new editor is here to give our customers a true one-stop shop for their document management.

Document Control
Grading matrix scoring nonconformities 1 to 4 by QMS impact and first or repeat occurrence
Sumatha Kondabolu

Understanding the MDSAP's nonconformity grading system

The MDSAP program contains a unique 2-step system for grading audit nonconformities. Learn how it works with our breakdown.

Audit
Alex Pavlović

When to submit a 510(k) vs. a Premarket Approval

File a 510(k) or apply for PMA? That is the question. Determining the best pathway to market for your medical device is key for success.

510(k)