From startups to enterprise pharma, quality teams around the world choose Qualio to ship products faster and stay audit-ready.
Angela at Akadeum Life Sciences.
Hallie at ViQi.
Mohamad, sole quality manager at Ender Diagnostics.
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An enterprise medical device team reduced audit prep from one week to one day and gained 360° visibility across their QMS
6 months
To ISO 13485, with no added quality headcount.
Cardiaccs
ISO 9001 certified in 7 months, with zero non-conformances. RMS built its first-ever quality system from scratch and passed ISO 9001 with zero non-conformances.
Six sister companies, one platform, zero audit findings. Distica unified six sister companies on Qualio, cut software validation from months to weeks, and passed its first ISO 13485 surveillance audit without a single comment.
Cutting ISO audit prep in half while tripling compliance coverage. Cogstate cut ISO 9001 surveillance audit prep by 50%, predicted more than 70% of auditor findings in advance, and is now pursuing three more frameworks in parallel.
AGADA Biosciences provides expert assistance with drug development programs from its base in Halifax, Nova Scotia.
How a UK pharma company unlocked 5x ROI, slicing consultant spend and accelerating strategic plans by 80% with Compliance Intelligence.
An enterprise medical device team reduced audit prep from one week to one day and gained 360° visibility across their QMS
Mindstep adopted Qualio's eQMS to streamline regulatory compliance, allowing them to focus on product development and achieve rapid certification success.
Discover how Tamer Mölnlycke Care achieved ISO 13485 compliance and audit success with Qualio, transforming their quality management in record time.
The quality team at Dublin's Wellcome-HRB Clinical Research Facility used Qualio to drive a new, agile clinical quality approach. The results were dramatic.
Effectum Medical wanted a best-in-class quality system for themselves, and also to share with their medical device clients to guide them to market. Here's what they did.
Expression Therapeutics needed a modern quality management system that didn’t rely on paper. Here's why they chose Qualio.
VitaCyte has found a powerful and adaptable quality management system in Qualio, which enables their team to accelerate their R&D efforts with confidence.
Enara Bio is a UK-based biotech start-up pushing the boundaries of cancer immunotherapy.
QA Specialist Bennett Klusas had just 3 months to upgrade his company's paper QMS to a fully digital, modern system. With Qualio, he hit his deadlines.
Logistics experts Warehouse Anywhere wanted to tap into the lucrative life science market - but a Word-based QMS and remote workforce made compliance tricky. Here's what they did.
Revision Skincare produces medical-grade, clinically tested skincare products that give customers healthy, beautiful and younger-looking skin.
CEO Phil Hayes-St Clair needed a new quality-first approach for his pioneering wellness business. A recommendation from an ex-TGA consultant opened a new chapter.
Akadeum Life Sciences makes isolation products leveraging the gentleness of buoyancy to capture chemical and biological targets.
Zalgen Labs manufacture diagnostic kits for the detection of deadly diseases, from Lassa and Ebola to SARS-CoV-2.
Californian start-up ViQi emerged from UC Santa Barbara and develops cloud-based image analysis software powered by AI and machine learning.
When Graham founded his biotech start-up, he knew he wanted to avoid the quality headaches of previous roles. Learn how Qualio set him 'flying' to success.
eClinical Solutions provides a cloud-based clinical data software platform which makes truly digital clinical trials possible.
Restech produces a suite of medical devices for minimally invasive diagnosis and treatment of reflux disorders.
SimBioSys is the developer of an innovative software as medical device (SaMD) platform to revolutionize 'computational oncology'.
NeuFit is the Austin-based manufacturer of Neubie, a neuromuscular electrical stimulation medical device.
InVivo Bionics is a Norwegian medical device company bringing a hybrid software/hardware device to market.
Kazmira is a Colorado-based manufacturer of hemp-based cannabinoid products, including CBD oils, tinctures, topicals and edibles.
LabPlex is a cannabis and hemp testing laboratory based in California.
TriMed is a California-based medical device manufacturer.
Bond Digital Health provides medical software which digitizes raw data from in vitro diagnostic devices such as COVID-19 lateral flow tests.
Watchmaker Genomics specializes in the protein engineering and enzyme manufacturing sector.
EvoEndo is the developer of a single-use gastroscope system which allows transnasal upper endoscopies to be performed without sedation or anaesthesia.
Ender Diagnostics is a Swiss developer and manufacturer of rapid molecular diagnostic kits for the detection of SARS-CoV-2.
30 Technology is a UK-based developer of therapeutic nitric oxide products.
StayinFront is a leading global provider of mobile cloud-based field force effectiveness and CRM software for life science organizations.
xCures is a health and wellness start-up that provides an advanced algorithmic AI platform connecting cancer patients to targeted oncology treatment.
Koneksa provides digital biomarker technology to clinical trial sponsors to unlock the remote capture of clinical data from patients.
CGX were struggling with a manual Excel-driven QMS which held back their product velocity. Qualio allowed them to build faster, sharper and leaner processes which boosted product output by 140%.
iMIX is a pharmaceutical company based in New Zealand that provides tailored medicines directly into hospital settings.
“Qualio gives us a 360-degree view of our compliance posture and automatically surfaces the gaps. We resolve issues faster, our team is more productive, and our risk is lower.”
Christophe DohrSite Quality Manager, Sentec
