Press Inquiries - QMS for Life Sciences - Qualio
Press Room
Find below a list of articles published by third-party websites and press releases from our blog.
- PR Newswire • October 14, 2025
Qualio announces Compliance Intelligence, the AI-powered solution advancing its industry-leading Life Sciences GRC platform
Qualio today announced general availability of Compliance Intelligence, a major new capability inside the Qualio Platform.
- Press Release • Mar 14, 2024
Qualio Leads QMS Market with Advancements In Document Management and New Executive Leadership
Company announces unique approach to Document Management capped by new OneDrive integration, providing unprecedented flexibility and control of content.
- Forbes • Jan 25, 2023
Four Predictions For A New Digital Life Science World In 2023
As the effects of Covid-19 begin to loosen their grip, fresh headwinds should start to emerge. I see a year of both challenge and opportunity ahead as life science companies look to strike a delicate balance between innovation and speed on one hand and the realities of an economic downturn on the other.
- Qualio • December 13, 2022
Qualio Nearly Doubles Global Customer Base of Life Sciences Leaders Using Its Preeminent Quality Management Solution
Company also updates industry-leading quality management solution to reduce time spent on administrative tasks and drive efficiencies in collaboration.
- Today's Medical Developments • December 12, 2022
Owning the quality management process
Medical device companies must commit to putting quality documentation and management at the heart of the design and manufacturing process to accelerate growth, achieve scale, and succeed with the FDA 510(k) process.
- Medical Design and Outsourcing • November 29, 2022
4 tips for medical device companies that are choosing a quality management system
The right quality management system can be instrumental for success, but how can medical device companies adopt a comprehensive process and platform that meets their current and future needs?
- PR Newswire • October 19, 2022
Qualio Launches Modern Validation Pack for the Life Sciences To Accelerate and Safeguard Quality and Compliance Processes
Qualio is announcing availability of their Validation Pack, which will help quality professionals in the life sciences sector take a faster, less resource-intensive approach to the latest Good Automated Manufacturing Practice (GAMP) and computerized system assurance (CSA) updates from the Food & Drug Administration (FDA).
- Forbes • October 6, 2022
Recalls Strongly Sway Consumer Healthcare Decisions—How Should Life Sciences Leaders Evolve To Build Trust?
If a pharmaceutical or medical device company suffers a serious hit to its reputation, such as an FDA warning letter or a product recall, consumers are dramatically less likely to engage with that brand as a whole in the future.
- ThinkBusiness • September 23, 2022
Irishman in the Valley: Qualio CEO Robert Fenton talks speed and velocity
Robert Fenton, the CEO of Irish-born but San Francisco-headquartered life sciences software player Qualio has ambitious plans for the business, and won’t let the current tech slowdown get in his way.
- Fierce Healthcare • September 23, 2022
Industry Voices—In a troubled economy, emerging medical device companies need to double down on driving efficiencies
Instead of diving in first and sorting it out later, medical device companies should take a measured, structured and data-driven approach to designing, manufacturing and documenting the quality of their products.
- MM+M • September 12, 2022
Report: Health-savvy consumers wise to recall issues
Nearly half of respondents who thought J&J’s vaccine was of lower quality than Pfizer’s attributed their belief to the FDA pause.
- Quartz • September 7, 2022
Best Companies for Remote Workers
Which companies are best for remote workers? Our ranking spotlights 83 employers who made the cut.
- Med-Tech Innovation News • September 7, 2022
Preparing to navigate FDA clearance to launch a new medical device
Heather Underwood, CEO of EvoEndo, talks about the lessons learned navigating through the FDA clearance process, and the preparation work that is required.
- Inc. • August 16, 2022
Inc. 5000 2022
Meet the Companies Winning in a Time of Change--And Achieving Spectacular Growth.
- Forbes • August 15, 2022
Building The Next-Gen Tech Stack For Life Sciences
We are in the midst of a once-in-a-lifetime evolution in the life sciences market, driven by the demand for healthcare innovations that can be delivered faster, better and safer than ever before. It is critical for life sciences companies to begin upgrading technology infrastructure to support this transformation.
- In Forma • August 1, 2022
Supply Chain Pressures No Excuse For Poor Quality Management
Drug manufacturers have been feeling the crunch from global supply chain issues, but the FDA will accept no excuses when it comes to quality and safety. How can manufacturers prepare for proposed changes to quality measurement requirements?
- PharmExec.com • July 29, 2022
Survey from Qualio Finds 50%+ of U.S. Consumers Refuse To Use a Healthcare Prescription or Product After a Recall
Qualio — the trusted cloud quality management system software for the entire life sciences ecosystem — announced a new survey of 2,002 U.S. consumers of healthcare products.
Qualio led this survey to better understand how far-reaching quality-related product recalls are when it comes to consumer trust and healthcare-specific purchasing decisions.
- Formulary Watch • July 28, 2022
Survey: Consumers Want More Transparency about Drug Quality
U.S. consumers are taking drug recalls and quality issues seriously, according to a new survey of more than 2,000 people conducted by Qualio, a provider of quality management systems. In fact, more than half (51%) of adults are unlikely to use a prescription drug that has experienced a recall, regardless of whether that issue was fixed.
- Press Release • July 27, 2022
Survey from Qualio Finds 50%+ of U.S. Consumers Refuse To Use a Healthcare Prescription or Product After a Recall
Qualio — the trusted cloud quality management system software for the entire life sciences ecosystem — announced a new survey of 2,002 U.S. consumers of healthcare products. The survey uncovered that recalls and related quality issues have a pronounced and enduring impact on purchases of drugs, devices, therapies, and other healthcare products.
- The Incrementalist • June 24, 2022
The Incrementalist: Quality and Speed for Healthcare Life Sciences with Robert Fenton from Qualio
Host Dr. Nick van Terheyden, aka Dr. Nick, discusses Quality and Speed for Healthcare Life Sciences with Robert Fenton, CEO & Founder of Qualio. Their discussion includes moving quickly and safely in Pharma and BioTech, quality management solutions and software to meet complex regulatory compliance requirements without sacrificing speed to market.
- QualityDigest • June 23, 2022
Qualio Focuses on Building a New, Collaborative Life Sciences Ecosystem
Qualio delivers time, cost, and efficiency savings while streamlining compliance activity.
- Press Release • June 8, 2022
Qualio Drives Global Expansion with a Focus on Building a New, Collaborative Life Sciences Ecosystem
Qualio — the trusted cloud quality management system for the entire life sciences ecosystem — announced significant growth in the first half of 2022.
- Inc • May 10, 2022
Best Workplaces 2022
These 475 Employers Have Cracked the Code for Excellent Company Culture. Here's How They Do It.
- Slice of Healthcare • May 2, 2022
2022 Predictions with Rob Fenton, Founder & CEO at Qualio
Our guest: 2022 Predictions with Rob Fenton, Founder & CEO at Qualio
- Lab Manager • April 14, 2022
The Benefits of Electronic Quality Management Systems
Lab managers need to evolve from paper-based quality management to more efficient solutions.
- Medical Alley • April 11, 2022
For the Record with Robert Fenton, Founder and CEO, Qualio
Robert Fenton is the founder and chief executive officer of Qualio. Prior to founding Qualio in 2012, Robert studied pharmacy for 5 years at University College Cork, practiced as a community pharmacist, and spent time in quality and R&D roles at global pharmaceutical companies such as Pfizer and Leo Pharma.
- Med-Tech Innovation • March 25, 2022
An Operation Warp Speed need for digital therapeutics
Kelly Stanton, director of quality at Qualio, explains why she feels there is a need for an Operation Warp Speed style approach to digital therapeutics in the U.S.
- Forbes • February 1, 2022
A New CTA For The Life Sciences In 2022: Move Fast And Connect (Not Break) Things
Based on insights and discussions with emerging life sciences leaders — companies like 4G Clinical, Ginkgo Bioworks and Medable — I believe four key trends will take hold in 2022 that will help paint a picture of the next-generation life sciences companies.
- Medsider • March 30, 2022
How to Maintain Velocity Without Sacrificing Quality: Interview with Qualio Founder and CEO Robert Fenton
For many, quality is viewed as a hurdle, slowing a project’s velocity, but Robert Fenton founder and CEO at Qualio is determined to change that reality for companies developing life-saving products.
- Fast Company • January 30, 2022
How to take your remote team building beyond Zoom happy hours
This software company founder hired a “people experience manager” to bring his remote teams together with flamenco classes and other shared cultural activities.
- HealthBiz - Podcast • January 6, 2022
Interview with Qualio CEO Robert Fenton
Unlike some of the legacy players, Qualio is used throughout the full life sciences ecosystem including by labs, CROs and packaging companies. And although many of the customers listed on Qualio’s website are on the smaller side, Robert boasts that many of the highest profile IPOs are clients and that some of the big boys who are household names use Qualio, too.
- HealthIT Answers • December 21, 2021
Digital Transformation in 2022
"In 2022, we expect open API adoption to skyrocket in adoption among emerging life sciences companies. Why? It’s simple – real-time insights and data integration capabilities are a core business differentiator and an enabler of both speed and innovation."
- Healthcare De Jure - Podcast • December 20, 2021
Healthcare de Jure - Robert Fenton, CEO Qualio
Guest Robert Fenton, CEO, Qualio, discusses teh impact of quality on life sciences development cycle, challenges created by data collection obligations, driving the build of good business not business for compliance; technology life cycle and power of new tools, COVID lessons of ability to move quickly.
- Business Post • November 17, 2021
100 Hot Start-Ups
Qualio has developed a quality management software platform for the life sciences sector, its mission being to enable life sciences teams developing live-saving products to get to market quickly and scale successfully.
- PR Newswire • November 9, 2021
Quality System Consultants and Qualio Form a Partnership
"What attracted us to Qualio was their firm commitment to trust, which is crucial to everything in this industry," said Paul Schwartz, President of Quality System Consultants.
- BIS Research • October 28, 2021
Emergence of Quality Management Software in Pharmaceutical Industry
VP of Operations, Rich Taylor spoke with Purvi Bhasin, a Research Analyst at BIS Research about how a quality management system plays a critical role in the healthcare industry, especially in the pharmaceutical segment.
- Qualio • November 3, 2021
Qualio Triples Size of Advisory Team, Introduces New Quality Management Services to Support Life Sciences Leaders in Expediting Go-to-Market
With Qualio Plus and Qualio Plus Audit, Life Sciences Companies Have a Full Scope of Quality Management Software and Services and a Team with Nearly a Century of Combined Quality Management Experience
- Authority Magazine • October 18, 2021
Robert Fenton of Qualio: Five Things You Need To Know To Successfully Manage a Remote Team
As a part of our series about the five things you need to successfully manage a remote team, I had the pleasure of interviewing Robert Fenton.
- Med-Tech Innovation • September 24th, 2021
Q&A: How a QMS can lead to quicker medical device launches
Robert Fenton, founder and CEO of Qualio, explains to Med-Tech Innovation News how its quality management system can help medical device companies launch their products faster.
- Med-Tech Innovation • August 26th, 2021
Qualio launches Design Controls for medical device quality management
Qualio — a cloud quality management system software for the entire life sciences ecosystem — has announced Design Controls for medical device and software as a medical device (SaMD) companies.
- Qualio • August 25th, 2021
Qualio Introduces Design Controls, a New Product To Help Medical Device Companies Launch and Scale Life-Saving Products
Design Controls brings product development and quality management together in one simplified and traceable cloud-based quality management system.
- Forbes • July 21st, 2021
Digital Health Funding Blasts Off And Showcases Promise Of Platforms
Quality management system platform for life sciences that recently secured $50M Series B funding round led by Tiger Global. Qualio is building out a network of partners in addition to its Life Sciences clients, seeking to leverage these relationships to establish Qualio as the commonly accepted protocol for quality management.
- Slice of Healthcare • July 7th, 2021
A Conversation with Robert Fenton, Founder & CEO at Qualio
“Qualio takes the pain out of quality management and regulatory compliance for the entire Life Sciences ecosystem.”
- ThinkBusiness • June 17th, 2021
How Irish-born Qualio is powering a global life sciences revolution
The next Irish unicorn? Robert Fenton believes the life sciences industry globally is going through a once-in-a-generation transformation and he has made sure to be part of it. He started Qualio in Ireland in 2012 and moved it to San Francisco where it now works with 250 life sciences companies worldwide to safely bring products to market.
- Forbes • May 25, 2021
This Cloud Startup Raised $50 Million To Help Biopharma Companies Automate Quality Control
“Everything we do is to support enabling teams to launch and scale life saving products,” says Fenton. “We do that by solving for the biggest data fragmentation problem that these companies have, which is their quality data. It's fragmented across different teams, tools, departments, locations, and we bring it all together in our product.”
- Qualio • May 25, 2021
Qualio Secures $50 Million in Series B Funding To Help Innovative Life Sciences Companies Unite Speed with Quality
Less than one year since the announcement of their $11 million Series A, Qualio — the trusted cloud quality management system software for the entire life sciences ecosystem — today announced their $50 million Series B funding round led by Tiger Global.
- ThinkBusiness • May 27, 2021
Irish-founded cloud business Qualio raises 50m
San Francisco-based Qualio, founded in Ireland by Robert Fenton in 2012, works with 250 life sciences companies worldwide to safely bring products to market.
- The Irish Times • May 25, 2021
Irish-founded software company Qualio raises $50m in funding
Qualio, a software company founded and led by Irishman Robert Fenton, has raised a further $50 million (€40.8 million) in funding less than a year after securing $11 million from investors.
- Irish Independent • May 25, 2021
Cork entrepreneur Robert Fenton raises €41m for cloud life sciences company Qualio
Qualio, the cloud life sciences company founded by Corkman Robert Fenton, has raised $50m (€40.8m) in a Series B funding round.
It brings to $63m (€51.4m) the total raised by the pharmacist who now runs the online quality management firm from San Francisco.
- Silicon Republic • May 25, 2021
Irish-founded Qualio raises $50m for life sciences software
Less than a year after its last funding round, the software start-up led by Irishman Robert Fenton has raised fresh funds.
- Irish Independent • July 24, 2020
The Big Tech Show: How I raised €10m in 3 months of lockdown
But how on earth did Corkman Robert Fenton, founder of life science data management firm Qualio, do it?
- San Francisco Business Times • July 21, 2020
Why Bay Area startups are getting slammed seeking seed and early stage investments
In part, the inability to meet face-to-face with investors and VCs is playing a huge role, say investors, providing context to these funding figures.