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Hear from our
happy customers

We partner with real quality professionals across the globe to help them innovate, get to market, ditch admin and cut stress.

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

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Karen Hue
Head of Quality & GxP Compliance, 30 Technology

"We looked a lot at how Qualio worked, its user interface and the technology behind it. It was by far the freshest, most logical eQMS system out there."

Dmitry ViQi
Dmitry Fedorov
CTO, ViQi

“The cost of our Qualio licenses is insignificant compared to what we've saved by just improving our processes.”

Peter Watchmaker
Peter Bruesehoff
Director of QA, Watchmaker Genomics

"Qualio is far superior to other systems I've worked with in the past. The flexibility has been mind-boggling."

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Michael Holcomb
QA Director, TriMed

"Document control took anywhere from 5 hours to 3 days. Now things get done in hours, even minutes. I can send training out in seconds now. Qualio has made my life 100% better!"

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Angela Pinkston
QA Manager, Akadeum Life Sciences

"Qualio helps me sleep better at night. Having that structure for everyone to work within is essential for us to really succeed this year in getting onto the market and staying compliant."

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Heather Underwood
CEO, EvoEndo

The easiest, stickiest and most impactful eQMS for quality professionals

Real people, real help

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How Angela's working life got '100% better' with Qualio

Hallie ViQi

"Said no person in an eQMS, ever!"

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

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How biotech president Graham made quality 'fun' in his company

All success stories

Industry
Media
Case study

From paper to digital biotech quality in 3 months

Vector BioMed is a Maryland-based manufacturer of lentiviral vectors used in gene therapies and medicines. The company wanted to adopt a ...
Case study

Millions of dollars in new revenue by removing a quality bottleneck

Warehouse Anywhere is a third-party logistics company offering storage and distribution support for thousands of companies across the US. Their ...
Cosmetics
Case study

Optimizing processes and sharpening quality

Revision Skincare produces medical-grade, clinically tested skincare products that give customers healthy, beautiful and younger-looking skin.
Medical device/SaMD
Case study

A bespoke quality system for a growing Australian wellness company

Drop Bio Health is an Australian at-home health technology company that delivers personalized, evidence-based health and wellness insight by ...
Medical device/SaMD
Case study

Transforming quality from one manager's problem to everyone's success

Akadeum Life Sciencesmakes isolation products leveraging the gentleness of buoyancy to capture chemical and biological targets.
Medical device/SaMD
Case study

'Firing on all cylinders' and saving lives with a medical device eQMS

Zalgen Labs manufacture diagnostic kits for the detection of deadly diseases, from Lassa and Ebola to SARS-CoV-2.
Medical device/SaMD
Case study

A shiny new digital quality platform twinned with expert help

Californian start-up ViQi emerged from UC Santa Barbara and develops cloud-based image analysis software powered by AI and machine learning.
Biotech
Case study

Why a biotech start-up's president sees his company 'flying' with Qualio

Tennessee-based Helix Biotech develops and manufactures lipid nanoparticles, liposomes and hybrid nanoparticles for customers, as well as producing ...
Medical device/SaMD
Case study

How a clinical software team aces over 50 audits a year

eClinical Solutions provides a cloud-based clinical data software platform which makes truly digital clinical trials possible.
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.
Medical device/SaMD
Case study

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

SimBioSys is the developer of an innovative software as medical device (SaMD) platform to revolutionize 'computational oncology'.
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

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.
Cannabis
Case study

How a cannabis testing lab got ready for market growth

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

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 anaesthesia.
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.
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.
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

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

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.
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 ...
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 ...
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 ...
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 ...
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 ...
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

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

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 ...
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 ...
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

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 ...
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 ...
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, ...
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 ...
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 ...
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 ...
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 ...
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 ...
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

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 PerCen ...
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 ...
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