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

30 Technology achieves faster ISO 13485 compliance with Qualio

30 Technology

AGADA Biosciences achieves stronger audit readiness with Qualio Compliance Intelligence

AGADA Biosciences

Chris Rice

Senior Quality Assurance Manager

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

Akadeum Life Sciences achieves 99% less quality admin and a stronger quality culture with Qualio

Akadeum Life Sciences

Alphazyme achieves rapid, scalable molecular enzyme production with Qualio

Alphazyme

Christopher Benoit

Chief Executive Officer

Alphazyme accelerates compliant enzyme development with Qualio

Alphazyme

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

ArcScan

Andrew Levien

Chief Executive Officer

Bond Digital Health achieves ISO 13485 and IEC 62304 compliance with Qualio

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

CGX boosts product output by 140% with Qualio

CGX

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

Drop Bio Health builds a bespoke quality system for growth with Qualio

Drop Bio Health

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

eClinical Solutions

Evan Grunbaum

VP of Quality & Compliance

Head of QM & RA

eHealth Technologies achieves SOC 2 Type II Certification with Qualio

eHealth Technologies

Colin Rhodes

Chief Technical Officer

Enara Bio builds a future-ready quality system with Qualio

Enara Bio

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

Enara Bio

Kate Nicholson

Head of Business & Portfolio Optimization

Ender Diagnostics builds a cloud-based eQMS and passes ISO 13485 audits with Qualio

Ender Diagnostics

Mohamad El Zein

Quality Manager

EvoEndo streamlines quality management and FDA compliance with Qualio

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

Director of Quality

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

InVivo Bionics

Daniel Aragao

Chief Technology Officer

InVivo Bionics doubles speed to market with Qualio

InVivo Bionics

IRISYS achieves streamlined QA and FDA-ready compliance with Qualio

Irisys

Adolfo Ramirez

Director of Information Systems and Data Compliance

Kazmira builds a paperless, audit-ready quality system with Qualio

Kazmira

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 with Qualio

Koneksa

Stan Spagnuolo

Director of Quality Assurance

LabPlex strengthens cannabis quality and compliance with Qualio

LabPlex

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

Linical streamlines quality and regulatory compliance with Qualio

Linical

LogixX Pharma achieves 5x ROI with Qualio Compliance Intelligence

LogixX Pharma

Michael Close

Chief Executive Officer

Empowering a start-up to take on a regulated market

Mindstep

Aaron Lin

Chief Operating Officer

NeuFit achieves faster audits and better quality control with Qualio

NeuFit

Proscia achieves MDSAP certification and global market access with Qualio

Proscia

Barbara Young

Senior Quality Manager

Restech achieves paperless quality management and audit-ready compliance with Qualio

Restech

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

Restech

Lowell Hoffman

Director of Quality Assurance

Revision Skincare streamlines quality processes with Qualio

Revision Skincare

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

Revision Skincare

Savneet Cheema

Senior Quality Manager

Sentec achieves faster audit prep and stronger compliance with Qualio Compliance Intelligence

Sentec

Christophe Dohr

Site 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

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

SimBioSys

StayinFront achieves global quality consistency and faster onboarding with Qualio

StayinFront

Holly Rundle

Director of Compliance

Tamer Mölnlycke Care achieves ISO 13485 compliance and audit success with Qualio

Tamer Mölnlycke Care

Tamer Mölnlycke Care achieves audit-ready ISO 13485 compliance with Qualio

Tamer Mölnlycke Care

Omran Falemban

QEHS and Regulatory Manager

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

Quality Assurance Specialist

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

ViQi

Dmitry Fedorov

Chief Technology Officer

ViQi achieves FDA-ready quality management with Qualio

ViQi

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

VitaCyte

Andrew Breite

Director of Quality Assurance

Director of Quality

Watchmaker Genomics gets quality right first time with Qualio

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

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

Zalgen Labs strengthens quality management and accelerates device readiness with Qualio

Zalgen Labs

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Qualio B2B Case Studies & Customer Successes

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