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The Qualio Blog

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

Alex Pavlović

Everything you need to know about the FDA 510(k) submission

Almost half of all US medical devices pass through the 510(k) process. We've built the ultimate guide of everything you need to get your device to market.

510(k)
16 G2 Fall 2023 badges for Qualio, including Leader, Momentum Leader and Best Usability
Alex Pavlović

Best life science vendor, best usability, best set-up, best results! Qualio at G2 Fall 2023

G2's results are in - and Qualio officially offers the best relationship, usability, set-up and real results of any life science eQMS vendor! Learn more here.

Company news
Qualio Analytics showing supplier audits by time and by sponsor, due and overdue
Emma Hanley

Fresh features and time-saving shortcuts in our latest product release

Our July Launch Train brings a host of time-saving and effort-erasing features and tweaks to make our customers' lives even easier. Here's what's coming!

eQMS
Meg Sinclair

PMA submissions: 4 PMA application methods for medical devices

Learn the key steps of the FDA's Pre-Market Approval (PMA) submission process and the different types of PMA applications for your medical device.

FDA
Meg Sinclair

Guide to 21 CFR Part 11 compliance [free checklist]

FDA 21 CFR Part 11 compliance is a crucial requirement for regulated companies. Learn how to comply by giving yourself airtight control of your electronic records and signatures.

FDA
Jerry Adatsi

PMA meaning: understanding FDA pre-market approval

Learn what you need to know about the rigorous FDA PMA process including preparing data, documentation and more.

FDA
Drug development stages from discovery to production, mapped to GLP, GCP and GMP requirements
Lisa Helmonds

What is GxP in pharma?

Explore the fundamentals of GxP in pharmaceutical settings and learn how to maintain compliance with GxP standards.

GxP
Sumatha Kondabolu

21 CFR Part 820: the complete overview

Find out everything you need to know to comply with FDA 21 CFR Part 820, the FDA's quality system requirements for medical devices.

FDA
Lola Furlong

Guide to ICH E6 (R3): changes and preparation

Review the latest GCP guidelines coming in ICH E6 (R3). Learn what's changing and how to prepare your team.

ICH