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The Qualio Blog
Insights on product development, quality management, and regulatory compliance for teams building life-saving products.
Meg Sinclair
The 6 most common triggers for FDA 21 CFR 820 non-compliance in 2022
Where are US medical device companies going wrong with their 21 CFR 820 compliance? Form 483 inspectional observations reveal the most common non-conformance triggers.
Medical Devices
Kelly Stanton
Taking diagnostics to the future with Mehdi Maghsoodnia, CEO of 1Health
Today we’re talking to Mehdi Maghsoodnia, Co-founder of 1Health which is a personalized precision medicine powered by a lab testing platform that...
Podcast
Robert Fenton
2023 is nearly here. Time to reflect on another successful year!
Company awards, product evolution, and a tenth birthday! As the year draws to an end, our CEO Rob Fenton looks back on a successful 2022 at Qualio.
Company news
Alex Pavlović
Qualio smashes customer review records at G2 Winter 2023 Awards
We're ending the year in style, by winning more G2 awards than we've ever won before! Take a look at our haul here.
Industry Awards
Alex Pavlović
Even faster and easier training with Training Plans
We just made rapid organizational training at scale even easier for our customers with our brand new Training Plans functionality. Learn more here!
Product Updates
Alex Pavlović
510(k) exempt medical devices: how to tell if you need to submit
Unsure if your medical device is exempt from the FDA's 510(k) submission pathway? Here's a handy guide.
510(k)
Kelly Stanton
Modernizing the Lab with Nathan Clark Cofounder of Ganymede
Nathan Clark of Ganymede talks about how the biotech lab of the future will look like on From Lab to Launch
Podcast
Alex Pavlović
The 5 best pharmaceutical consultants to work with in 2023
Need the help of a pharma or biotech expert in 2023? We've hunted down 5 consultants that should be on any shortlist.
Pharmaceutical
Meg Sinclair
The 4 best ISO 13485 audit checklists
These 4 free ISO 13485 audit checklists will help you achieve ISO 13485 compliance, prepare for certification and pass an audit.
Medical Devices