Natural and easy FDA compliance
Challenge
The Food & Drug Administration is the life science gatekeeper for 330 million people in the world's largest economy.
Getting your life-saving product to market means hawk-like inspection in accordance with some of the world's highest quality and compliance standards.
Some companies never make the cut.
Solution
The FDA wants life science companies to digitize their quality approach.
eQMS platforms like Qualio make compliance natural and automatic by boosting control, sharpening visibility and unlocking complete control of the quality landscape.
Electronic quality =
unshakeable FDA compliance.
How it works
FDA 21 CFR Part 11 compliance
- All major system actions, from document review to training completion and event close-out, underpinned by Part 11-compliant e-signatures
- Incorruptible audit trails give complete traceability and accountability
- GDocP and ALCOA+ system guardrails give you a controlled, compliant single source of truth for all your quality records
FDA 21 CFR Part 820 compliance
- Provides all functionality for a holistic, digital medical device QMS, from design controls to training and CAPA management
- Embed a risk-based, right-first-time approach underpinned by automated workflows and audit trails
- Used by hundreds of medical device companies to demonstrate quality and compliance and get their devices to market
510(k) submission
- Easily combine and control all the ingredients of your 510(k) submission, from device safety data to substantial equivalence documents
- Build a mature and digitally connected quality, risk and design control approach for a safe, cleared device
- Shave months from your prep time
Premarket Approval (PMA) submission
- Prove you have the robust quality system you need for a Class III medical device
- Pinpoint gaps, cut risk and enjoy end-to-end, real-time visibility of your device's design and development pathway
- Pull design elements straight from your other systems with instant integration
cGMP
- Automated digital control of documents, training, quality events, suppliers and design controls embed the manufacturing best practice of the Quality System Regulation
- Eliminate manual admin and refocus your time towards continuously improving good practice
- Keep up with FDA expectations with an agile, scalable, cloud-based eQMS connecting all corners of your business
FDA clearance resources
Everything you need to know about 510(k) submissions
Access our comprehensive end-to-end guide for your medical device's FDA 510(k) submission.
What your QMS needs for
FDA & ISO regulation
Do you know what your QMS needs to make your FDA inspector happy? Find out with our webinar.
Don't just take our word for it!
Hear from our many happy customers
"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"When I recommend Qualio, one of the first things I say is: you're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources.
That's unique in this industry."
Becki N.
Quality & Regulatory Lead, Synthego
“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
"I joined in November. I contacted Qualio 2 weeks later. We went live mid-December. We had all users working in the system by January. And we had our ISO 13485 certification by July.
Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
"We’ve been able to show certain clients what we’ve accomplished with Qualio, and they were very impressed.
The VP of Quality for a client company said, "If I could build from the bottom up, I’d do it exactly the way you guys did it"."
Stephana P.
VP of Quality, Alphazyme
"There are other eQMS providers that are very well-established, but not particularly accessible to organizations that don't have the fundamental basics in place.
Qualio is not overly complicated. It gives us those foundational aspects of a quality system in a way that people can actually get behind."
Phil C.
Quality Manager, Bond Digital Health
"The perfect QMS system for a start-up. Everything, from validation to migration and training, was a positive experience."
Drew M.
Director of Quality, ECM Therapeutics
"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one FTE.
Qualio has given us one more staff member in a company where we throw nickels around like manhole covers!"
Mike T.
VP of IT & Information Security, xCures
“The cost of our Qualio licenses is insignificant compared to what we've saved by just improving our processes.”
Peter B.
Director of QA, Watchmaker Genomics
"The Qualio team made a big difference to our company by providing amazing help and guidance at a critical time in our QMS development."
Jackie L.
Managing Director, Auxilio Pharmaceuticals
"Set-up is easy and very user-friendly. Qualio gets rid of the paperwork. Simple to use, affordable."
Rachel A.
Medical Outreach Specialist, eHealth Technologies
“We evaluated all players on the market and came up with Qualio as the best balance of price, capability, and quality of support.”
Jeffrey B.
CEO, FifthEye
“Once you understand how Qualio works, it's really easy to plan out processes and put them into place within the QMS.”
Sara V.
Quality Manager, Leaseir Technologies
"My favourite thing is how Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
"Any intelligent person would look at Qualio and say, "This is exactly what a cloud-based system should do". But when you actually see it in action, you still think it's pretty cool."
Andrew L.
CEO, ArcScan
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
"I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us reduce our workload and our paper trail."
Paul M.
CEO, Arann Healthcare
"Qualio+ fits right in to ensure a smooth transition to an eQMS. The team offered excellent advice every step of the way."
Chris S.
Quality Manager, CureMetrix
"The validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support and chat function."
Soni M.
QA/RA Director, NovoSource
"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
"Qualio has been great to work with. We implemented an entire QMS with them! Intuitive functionality, friendly staff."
Kim K.
Executive VP of Operations, VirTrial
"A big step up for our small company. Much easier than digging through a file repository manually!"
Matt S.
Senior Software Engineer, ArcScan
"Now that we’re electronic, we can grow to 500 or 1,000 employees.
Since we don’t need to grow the QA team as much, we can put more resources into employees who make us money, like scientists and manufacturing personnel."
Adolfo R.
Director of Information Systems & Data Compliance, IRISYS
"With other vendors, we felt like just a number.
But this is like a true partnership. Qualio has definitely changed our world."
Eric D.
Director of Quality Assurance, Expression Therapeutics
“Qualio enabled us to seamlessly work through our ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally.”
David H.
CEO, Surfatek
The support Kelly and the team gave us at the beginning was great and we were really leveraging them to build out our QMS from scratch.
It was so streamlined, it was so efficient, they were super helpful and communicative.
That's exactly what we needed - and that's why we went with Qualio.
Heather U.
CEO, EvoEndo