Chat Icon CUSTOMER SUCCESS STORIES

Learn from our successful customers

We partner with quality professionals to help them innovate, evolve and get to market. Hear real stories and testimonials from our happy customers.

Medical device/SaMD

I joined in November. I contacted Qualio 2 weeks later. We went live mid-December. We had all users in the system by January. And we had our ISO 13485 certification by July. Without Qualio, we'd never have done that.

karen-hue
Karen Hue
Head of Quality & GxP Compliance, 30 Technology
CRO/CMO

Qualio’s become a verb here. When people need
things, Qualio is the word that’s used.

Chris Rice AGADA
Chris Rice
Quality Assurance Associate, AGADA Biosciences
Medical device/SaMD

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-levien
Andrew Levien
CEO, ArcScan
Biotech

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-petrino
Stephana Petrino
VP of Quality, Alphazyme
Medical device/SaMD

Qualio is not overly complicated. It gives us the foundational aspects of a quality system in a way that people can actually get behind.

Phil Cooley Bond Digital Health
Phil Cooley
Quality Manager, Bond Digital Health
Pharmaceutical

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.

beckinam-nowatzke-75bcea77
Beckinam Nowatzke
Quality & Regulatory Lead, Synthego
CRO/CMO

Qualio shows we're taking quality seriously and investing in quality improvement initiatives. We plan to keep growing with Qualio, offering visibility, continuous improvement and knowledge management to our current and potential customers.

Edgar Gimenez The Dot
Edgar Gimenez
Quality Assurance Specialist, The Dot
Medical device/SaMD

We evaluated all players on the market and came up with Qualio as the best balance of price, capability, and quality of support.

Jeffrey Basch FifthEye
Jeffrey Basch
Chief Financial Officer, FifthEye
Pharmaceutical

Qualio keeps us in a constant state of audit readiness.

Deb Glancy Dimension
Deb Glancy
Director of Quality, Dimension Therapeutics
CRO/CMO

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 Ramirez
Adolfo Ramirez
Director of Information Systems & Data Compliance, IRISYS

The easiest, stickiest and most impactful eQMS for quality professionals

Nuggets from happy customers

thumbnail_video-snippet-30technology-1

How Karen, head of quality & GxP, went from 0 to 13485 in 6 months

thumbnail_video-snippet-evoendo

Why medical device CEO Heather sleeps better at night knowing Qualio is in place

thumbnail_video-snippet-ender

How Qualio helped Mohamad, a sole quality manager, set up an ISO 13485 QMS that passes audits

thumbnail_video-snippet-leaseir

What medical device quality manager Sara likes best about using Qualio

All success stories

Industry
Media
Podcast
Medical device/SaMD

Expanding Med Device Distribution Internationally and in China

Andy Levien, President and CEO of ArcScan talks to Robert about expanding his medical device company ...
Podcast
Medical device/SaMD

Lessons from Building an Open Source Quality Community with Gill Berry

  Gillian Berry is a qualified clinical nurse specialist and founder of PerCen Technologies. She founded ...
Medical device/SaMD
Case study

How Qualio empowered Bond Digital Health with an SaMD QMS from scratch

Bond Digital Health provides medical software which digitizes raw data from in vitro diagnostic devices such as COVID-19 lateral flow tests.
Case study
Life sciences

Cirris ensures quality products and achieves AS9100 certification

Cirris is a manufacturing company based in Utah that makes cable and harness testing equipment to ensure their customers’ products, which range from ...
Biotech
Case study

Expression Therapeutics optimizes document management with Qualio

Expression Therapeutics, Inc. is a fully integrated clinical stage gene and cell therapy company developing novel, potentially curative, therapeutics ...
Medical device/SaMD
Case study

How 30 Technology found the perfect eQMS for faster, smarter quality management

30 Technology is a  UK-based developer of therapeutic nitric oxide products.
CRO / CMO
Case study

IRISYS uses Qualio for smart, FDA-approved contract development and manufacturing

IRISYS is a contract development and manufacturing organization (CDMO), headquartered in San Diego, that helps biotech and pharmaceutical firms ...
Medical device/SaMD
Case study

How a medical device company doubled their speed to market

InVivo Bionics is a Norwegian medical device company bringing a hybrid software/hardware device to market.
Cannabis
Case study

How CBD manufacturer Kazmira earned trust in a transitioning market

Kazmira is a Colorado-based manufacturer of hemp-based cannabinoid products, including CBD oils, tinctures, topicals and edibles.
Podcast
Medical device/SaMD

CureMetrix Helps Radiologists Make Better, Faster Decisions With AI

It’s no secret the pandemic kept many people at home for the bulk of the last year. At the same time, businesses that weren’t deemed essential were ...
Pharmaceutical
Case study

iMIX rapidly delivers tailored treatments to patients

iMIX is a pharmaceutical company based in New Zealand that provides tailored medicines directly into hospital settings. To illustrate, imagine a ...
Biotech
Case study

VitaCyte uses Qualio to manufacture highly purified cell recovery reagents

VitaCyte is a biotechnology company that manufactures high-purity tissue dissociation enzymes and cell recovery reagents, including collagenase. The ...
CRO / CMO
Case study

How The Dot rolled out a CMO eQMS 'in record time'

The Dot is a contract manufacturing firm that manages test kit assembly, relabeling, fulfillment, logistics, and distribution for clients and also ...
Podcast
Medical device/SaMD

Using AI to Improve Healthcare Outcomes and Access with Sam Dribin

  Sam Dribin is the Chief Technology Officer for CureMetrix, an AI company focused on solutions that support ...
Podcast
Medical device/SaMD

How to Maintain a Quality Culture during Explosive Growth

  Today’s guest is Kristinn Gylfason, Compliance Officer at Sidekick Health and a lawyer who specializes in ...
Medical device/SaMD
Case study

Why Watchmaker Genomics chose Qualio to get quality right first time

Watchmaker Genomics specializes in the protein engineering and enzyme manufacturing sector.
Medical device/SaMD
Case study

CGX boosts product output by 140% with Qualio

CGX is one of the world’s leading manufacturers of dry electrode EEG headsets, designed for researchers in the fields of simulation training and ...
Case study
Life sciences

How StayinFront stayed in front with their eQMS system

StayinFront is a leading global provider of mobile cloud-based field force effectiveness and CRM software for life science organizations.
Medical device/SaMD
Case study

From treading water to real quality improvement

NeuFit is the Austin-based manufacturer of Neubie, a neuromuscular electrical stimulation medical device.
Medical device/SaMD
Case study

We asked EvoEndo's CEO how Qualio has impacted her business

EvoEndo is the developer of a single-use gastroscope system which allows transnasal upper endoscopies to be performed without sedation or ...
Medical device/SaMD
Case study

How Ender Diagnostics' quality manager built an in vitro medical device QMS with Qualio

Ender Diagnostics is a Swiss developer and manufacturer of rapid molecular diagnostic kits for the detection of SARS-CoV-2.
Podcast
Medical device/SaMD

Launching the First Single-use Endoscope for Unsedated Pediatric Endoscopy with Dr. Heather Underwood, CEO of EvoEndo

  Today’s guest is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated ...
Medical device/SaMD
Case study

Koneksa saves a week per month and uses it for continuous improvement

Koneksa provides digital biomarker technology to clinical trial sponsors to unlock the remote capture of clinical data from patients.
Medical device/SaMD
Case study

ArcScan helps improve diagnostic, patient and surgical outcomes with Qualio

ArcScan is a medical device manufacturer that builds high-resolution ultrasonic imaging devices for the eye. These products help doctors see through ...
Podcast
Medical device/SaMD

Funding and Scaling your Med Device Startup with Jen Baird

  Getting funding and scaling a medical device business alone is challenging. But challenges don't deter ...
Medical device/SaMD
Case study

Lifting a weight from the quality team's shoulders by going paperless

Restech produces a suite of medical devices for minimally invasive diagnosis and treatment of reflux disorders.
Podcast
Quality culture

Quality Management Fundamentals in Aerospace and Life Sciences

  Cables are everywhere, quite literally. Quality management for a cable testing company can be challenging, ...
Cannabis
Case study

How a cannabis testing lab got ready for market growth

LabPlex is a cannabis and hemp testing laboratory based in California.
CRO / CMO

Linical uses Qualio to streamline CRO efforts and help biotech and pharma companies secure regulatory approval

Linical is a global contract research organization (CRO) that provides expertise to pharmaceutical and biotech companies to help them bring drug ...
Podcast
Biotech

Improving the State of Cell Isolation & Recovery with Andrew Breite from VitaCyte

  Today's guest, Andrew Breite, Director of Quality at VitaCyte, discusses VitaCyte's contributions to cell ...
Medical device/SaMD
Case study

Fix The Mask uses Qualio+ to market a medical device in record time mid-pandemic

Fix The Mask is a medical device organization with a simple mission: to help everyone stay healthy during the COVID-19 pandemic by wearing ...
Medical device/SaMD
Case study

How xCures built a compliant, controlled eQMS for their 2022 plans

xCures is a health and wellness start-up that provides an advanced algorithmic AI platform connecting cancer patients to targeted oncology treatment.
Medical device/SaMD
Case study

Sidekick Health chooses Qualio+ for audit-readiness

Sidekick Health is a software company founded by medical doctors and specialists that operates a gamified digital care platform designed to help ...
Medical device/SaMD
Case study

Building a 510(k) market-ready QMS in 90 days

SimBioSys is developing a software as medical device (SaMD) platform to revolutionize 'computational oncology'.
Medical device/SaMD
Case study

Third time's the charm for a Class III medical device manufacturer

TriMed is a California-based medical device manufacturer.
Podcast
Quality culture

Defining Quality: The Role, Responsibilities, and Industry

  Today we're excited to have Laura Araujo, Vice President of Quality at 4G Clinical share her insight into ...
Medical device/SaMD
Case study

Proscia uses Qualio to bring high-quality medical device software to pathologists around the world

Since 2014, Proscia has been building software solutions for pathology and cancer research. The company recently decided to apply their software to a ...
Biotech
Case study

Alphazyme uses Qualio to produce molecular enzymes at scale for biotech companies

Alphazyme is a biotechnology manufacturer headquartered in Jupiter, Florida that produces custom enzymes used by large-scale biotech companies to ...
FANCY BEING OUR NEXT CUSTOMER?

No pressure, of course. Just get in touch and tell us what you're looking for.