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

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CUSTOMER SUCCESS STORIES

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

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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.

Karen Hue

Head of Quality & GxP Compliance, 30 Technology

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"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 Fedorov

CTO, ViQi

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

Peter Bruesehoff

Director of QA, Watchmaker Genomics

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

Michael Holcomb

QA Director, TriMed

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"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!"

Angela Pinkston

QA Manager, Akadeum Life Sciences

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"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."

Heather Underwood

CEO, EvoEndo

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

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"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

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All success stories

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Pharmaceutical Case study

Turning audit prep into continuous improvement with Compliance Intelligence

AGADA Biosciences provides expert assistance with drug development programs from its base in Halifax, Nova Scotia. Read story

Pharmaceutical Case study

5x return on investment with Compliance Intelligence

UK-based LogixX Pharma specializes in the commercialization of life science products, marketing and distributing a range of innovative ... Read story

Medical Devices Case study

How Sentec cut audit prep 80% with Compliance Intelligence

Sentec is a Swiss-American medical device company specializing in respiratory care and non-invasive monitoring. The company sells its medical device ... Read story

SaMD Case study

Empowering a start-up to take on a regulated market

Mindstep is a digital front door platform for mental health and mental fitness, leveraging AI to provide clinical assessments, care, and onwards care ... Read story

Medical Devices Case study

Impressing auditors and maintaining ISO 13485 compliance

Tamer Mölnlycke Care is a joint venture between the Swedish Mölnlycke Healthcare and the Tamer Group, based in the latter's native Saudi Arabia. The ... Read story

Clinical Trials Case study

Hitting new heights of clinical quality with Qualio

The Wellcome-HRB Clinical Research Facility (CRF) is a state-of-the-art clinical research partnership between Saint James' Hospital and Trinity ... Read story

Medical device/SaMD Case study

Quality excellence for a medtech consultancy - and their clients

Switzerland-based Effectum Medical offers a hands-on, collaborative partnership to help its medical device customers innovate and embed lasting ... Read story

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 ... Read story

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 ... Read story

Case study

Positioning a biotech start-up for long-term success

Enara Bio is a UK-based biotech start-up pushing the boundaries of cancer immunotherapy. Read story

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 ... Read story

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 ... Read story

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. Read story

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 ... Read story

Medical device/SaMD Case study

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

Akadeum Life Sciences makes isolation products leveraging the gentleness of buoyancy to capture chemical and biological targets. Read story

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. Read story

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. Read story

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 ... Read story

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. Read story

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. Read story

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'. Read story

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. Read story

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. Read story

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. Read story

Cannabis Case study

How a cannabis testing lab got ready for market growth

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

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. Read story

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. Read story

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. Read story

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. Read story

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. Read story

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. Read story

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. Read story

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. Read story

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. Read story

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 ... Read story

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 ... Read story

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 ... Read story

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 ... Read story