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?
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).
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.
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.
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.
Nearly half of respondents who thought J&J’s vaccine was of lower quality than Pfizer’s attributed their belief to the FDA pause.
Which companies are best for remote workers? Our ranking spotlights 83 employers who made the cut.
Heather Underwood, CEO of EvoEndo, talks about the lessons learned navigating through the FDA clearance process, and the preparation work that is required.
Meet the Companies Winning in a Time of Change--And Achieving Spectacular Growth.
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.
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?
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.
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.
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.
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.
Qualio delivers time, cost, and efficiency savings while streamlining compliance activity.
These 475 Employers Have Cracked the Code for Excellent Company Culture. Here's How They Do It.
Our guest: 2022 Predictions with Rob Fenton, Founder & CEO at Qualio
Lab managers need to evolve from paper-based quality management to more efficient solutions.
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.
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.
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.
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.
This software company founder hired a “people experience manager” to bring his remote teams together with flamenco classes and other shared cultural activities.
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.
"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."
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.
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.
"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.
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.
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
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.
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.
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.
Design Controls brings product development and quality management together in one simplified and traceable cloud-based quality management system.
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.
“Qualio takes the pain out of quality management and regulatory compliance for the entire Life Sciences ecosystem.”
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.
“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.”
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.
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.
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.
Less than a year after its last funding round, the software start-up led by Irishman Robert Fenton has raised fresh funds.
But how on earth did Corkman Robert Fenton, founder of life science data management firm Qualio, do it?
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.