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SaMD
Case study
• June 23, 2025

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 ...
Medical Devices
Case study
• June 17, 2025

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 ...
Clinical Trials
Case study
• February 25, 2025

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 ...
Medical device/SaMD
Case study
• July 26, 2024

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 ...
Biotech
Case study
• July 26, 2024

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
• July 26, 2024

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 ...
Case study
• March 25, 2024

Positioning a biotech start-up for long-term success

Enara Bio is a UK-based biotech start-up pushing the boundaries of cancer immunotherapy.
Case study
• February 12, 2024

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
• October 30, 2023

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
• October 24, 2023

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
• June 20, 2023

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
• June 05, 2023

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.
Medical device/SaMD
Case study
• April 13, 2023

'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
• February 02, 2023

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
• January 17, 2023

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
• December 12, 2022

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
• December 02, 2022

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
• December 02, 2022

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
• September 13, 2022

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
• September 06, 2022

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
• August 25, 2022

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
• August 24, 2022

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
• August 23, 2022

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
• June 27, 2022

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
• June 17, 2022

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
• June 15, 2022

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
• June 01, 2022

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
• May 10, 2022

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
• April 07, 2022

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
• March 28, 2022

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
• January 25, 2022

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.
CRO / CMO
• November 09, 2021

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
• November 09, 2021

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 ...
Biotech
Case study
• November 09, 2021

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
• November 09, 2021

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 ...
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