Qualio B2B Case Studies & Customer Successes

Qualio is a cloud-based quality management software system designed for life science companies. Qualio empowers medical device, pharmaceutical, biotech, and contract organizations to get to market faster, boost revenue, and cut risk. Over 500 companies in 80 countries use Qualio to embed and automate GxP, FDA, and ISO compliance. Qualio unites your teams, processes, and data in a single source of truth that supports a culture of quality and makes your business stronger, fitter, and more competitive.

30 Technology achieves ISO 13485 certification in 6 months and a 97% reduction in quality task time with Qualio

30 Technology

Karen Hue

Head of Quality & GxP Compliance

Akadeum Life Sciences achieves a 99% reduction in quality admin time and a culture of quality ownership with Qualio

Akadeum Life Sciences

Angela Pinkston

Quality Assurance Manager

Alphazyme achieves rapid, scalable molecular enzyme production with Qualio

Alphazyme

Christopher Benoit

Chief Executive Officer

ArcScan achieves an audit-ready, scalable eQMS and faster approvals with Qualio

ArcScan

Andrew Levien

Chief Executive Officer

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

Bond Digital Health

Phil Cooley

Quality Manager

Cardiaccs AS achieves 2x faster ISO 13485 certification with Qualio

Cardiaccs AS

Jonas Tyssø

Project and Quality Manager

CGX achieves faster 510(k) filing and increased product output with Qualio

CGX

Spencer Linton

CGX's General Manager

Cirris achieves AS9100 certification and audit-ready quality with Qualio

Cirris

Gene Vought

Quality Manager

Drop Bio Health achieves TGA & ISO compliance and launches WellBeing with Qualio

Drop Bio Health

Phil Hayes-St Clair

Chief Executive Officer

eClinical Solutions achieves an audit-ready, scalable eQMS with Qualio

eClinical Solutions

Evan Grunbaum

VP of Quality & Compliance

Effectum Medical accelerates clients' time‑to‑market by 6 months with Qualio

Effectum Medical

Camilla Messerli

Head of QM & RA

eHealth Technologies achieves SOC 2 Type II Certification with Qualio

eHealth Technologies

Colin Rhodes

Chief Technical Officer

Enara Bio achieves 92% on-time training and streamlined document control with Qualio

Enara Bio

Kate Nicholson

Head of Business & Portfolio Optimization

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

Ender Diagnostics

Mohamad El Zein

Quality Manager

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

EvoEndo

Heather Underwood

Chief Executive Officer

Expression Therapeutics optimizes document management with Qualio

Expression Therapeutics

Eric Day

Director of Quality Assurance

Fix the Mask achieves rapid FDA-ready market launch with Qualio Plus by Qualio

Fix the Mask

Sabrina Paseman

Chief Executive Officer

Helix Biotech achieves a rapid, paperless GMP eQMS and faster close-outs with Qualio

Helix Biotech

Graham Taylor

President

iMIX achieves rapid, compliant delivery of tailored hospital medicines with Qualio

iMIX

Gareth Quinn

Director of Quality

InVivo Bionics achieves a faster, higher-quality route to market with Qualio

InVivo Bionics

Daniel Aragao

Chief Technology Officer

IRISYS achieves streamlined QA and FDA-ready compliance with Qualio

Irisys

Adolfo Ramirez

Director of Information Systems and Data Compliance

Kazmira achieves paperless, cGMP-ready quality control and 96% faster information retrieval with Qualio

Kazmira

Hanna Fanous

Quality Assurance Supervisor

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

Koneksa

Stan Spagnuolo

Director of Quality Assurance

LabPlex achieves audit-ready ISO 17025 compliance and 90% team engagement with Qualio

LabPlex

Valerie Orta

Quality Manager

Linical, a global CRO, achieves rapid deployment and streamlined document management with Qualio

Linical

Tyler Cochran

Executive Director of Quality

Proscia achieves MDSAP certification and global market access with Qualio

Proscia

Barbara Young

Senior Quality Manager

Restech achieves 0 non-conformances and 100% audit readiness with Qualio

Restech

Lowell Hoffman

Director of Quality Assurance

Revision Skincare achieves a paperless, streamlined eQMS and 20% faster inspections with Qualio

Revision Skincare

Savneet Cheema

Senior Quality Manager

Sidekick Health achieves audit-readiness and scalable quality management with Qualio eQMS

Sidekick Health

Kristinn Gylfason

Compliance Officer

SimBioSys achieves 510(k) readiness in 90 days with Qualio

SimBioSys

Hilary Baldwin

VP of Regulatory & Quality

How StayinFront stayed in front with their eQMS system

StayinFront

Holly Rundle

Director of Compliance

The Dot achieves supply-chain assurance and rapid eQMS deployment with Qualio

The Dot

Edgar Gimenez

Quality Assurance Specialist

TriMed achieves a configurable, scalable eQMS and faster quality outcomes with Qualio

TriMed

Michael Holcomb

Quality Assurance Director

Vector BioMed achieves a paperless, GMP-compliant eQMS in 3 months with Qualio

Vector BioMed

Bennett Klusas

Quality Assurance Specialist

ViQi achieves an FDA‑ready eQMS in 12 weeks with Qualio (software + Qualio+ support)

ViQi

Dmitry Fedorov

Chief Technology Officer

VitaCyte achieves streamlined quality management and accelerated R&D with Qualio

VitaCyte

Andrew Breite

Director of Quality Assurance

Warehouse Anywhere achieves rapid life‑science revenue growth and streamlined, cloud‑based quality with Qualio

Warehouse Anywhere

Caleb Walters

Director of Quality

Why Watchmaker Genomics chose Qualio to get quality right first time

Watchmaker Genomics

Maran Sprouse

Process Development & NPD Team Lead

Wellcome-HRB Clinical Research Facility achieves 50% reduction in protocol deviations and faster trial growth with Qualio

Wellcome-HRB Clinical Research Facility

Kishor Santhosh

Quality & Regulatory Affairs Manager

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

xCures

Mike Trudnak

Vice President of IT & Information Security

Zalgen Labs achieves a scalable, compliant paperless eQMS and 90% document digitization with Qualio

Zalgen Labs

Matt Boisen

Director of Diagnostics Development

No matching case studies

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