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

Alex Pavlović

The ultimate ISO 9001 overview: quality management systems

The ISO 9001 standard maps out the model for a modern, effective quality management system (QMS). Learn about all the elements of ISO 9001.

ISO 9001
Teena Hart

CureMetrix helps radiologists make better, faster decisions with AI

CEO Robert Fenton and Sam Dribin, CTO of CureMetrix, talk about how the technology company is using AI and medical imaging to improve healthcare for women.

eQMS
G2 2025 badges: Leader, Leader EMEA, Momentum Leader, Best Relationship, High Performer, Most Implementable, Best Usability, Best Results
Alex Pavlović

Kicking off 2025 with new G2 accolades from our customers

We're starting 2025 the right way: with fresh G2 badges and accolades from our happy customers! Check out what we won here.

eQMS
FDA CFR Title 21 Part 870 list of cardiovascular device classifications
Sumatha Kondabolu

The 3 FDA medical device classes: differences and examples explained

Learn about the 3 FDA medical device classes. We give comprehensive definitions, examples, and differences of Class I, II, and III devices.

FDA
Four areas quality assurance covers: process, product, organization and suppliers
Lola Furlong

Quality assurance vs. quality control explained: 5 key differences

Learn about the key quality assurance vs quality control (QA vs QC) differences, and how to apply both disciplines to your operation.

Quality management
December product update: Resource Library, 10+ integrations, post-market surveillance
Tina Karimi

Qualio leaps to the front of the pack in integrated eQMS providers

Our December 2024 product upgrade gives our customers unparalleled integration and flexibility for their vital quality processes. Learn what we did!

eQMS
Qualio Create event form with impact, probability and risk fields
Meg Sinclair

5 fundamentals of the CAPA quality process

Get a comprehensive understanding of the CAPA quality process. Learn how to identify root causes of compliance issues and avoid mistakes.

eQMS
Sumatha Kondabolu

Understanding post-market surveillance for medical devices

Post-market surveillance (PMS) helps you capture feedback about your medical device. Learn how to create a PMS plan and run a successful post-market surveillance program.

Medical Devices
Alex Pavlović

What you should know about the CE mark

The CE mark certifies that your product meets EU safety, health and environmental standards. Learn the essentials about CE marking, and how to secure yours.

Compliance