Meg has amassed over a decade of experience as a QA/RA and compliance professional, with a range of cross-functional skills and knowledge spanning from non-profits to medical device start-ups.
Meg is Senior Quality Specialist at Qualio, a member of the expert quality success team, and a certified auditor for both ISO 9001 and ISO 13485.
Part 11 has been stable since 1997. The number of systems it applies to has not. QMSR took effect in February 2026, and the FDA's updated Computer Software Assurance guidance pulled cloud and SaaS tools formally into scope. Here is how to run the checklist so the answers stay true.
Design inputs live in Jira. Test results live in TestRail. Complaints live in Zendesk. The reconciliation work in between is where quality capacity goes, and the FDA's 2026 guidance has already brought those systems inside your compliance perimeter.
Most quality management software evaluations cannot separate the field, because they measure what every vendor already does. Three questions that sort it.
One quality leader explains why AI needs to become a coworker, not just a sidekick, before audit prep stops being a last-minute scramble.
The EU expanded its MDR "well-established technologies" list again, growing it roughly fivefold. See which device categories now qualify for reduced requirements.
FDA's revised PAI guide takes effect August 2026, favoring risk-based reviews over onsite inspections by default. See what the shift actually rewards.
From algorithm to aisle: Naritas CEO Nora Keldy on why AI-native biotech companies can't separate scientific ambition from quality infrastructure — and what that means for how you build.
Why are more biopharma sponsors turning to functional service providers? Dr. Les Enterline of PPD breaks down the FSP model, the rise of mixed-model outsourcing, and what it really takes to flex clinical trial resources without sacrificing quality or control.
Healthcare has resisted digital transformation longer than any other industry. Four-time entrepreneur Mariano Valenio breaks down why -- and what AI, data, and continuous compliance are finally changing.
RCG Intel founder Joe Luminello on why context beats data, how to think deliberately about AI adoption, and what's creating paralysis for pharma and biotech companies right now.
Noreen Hong, VP and General Manager at Thermo Fisher Scientific, shares 28 years of career lessons on leadership, sustainability, AI in the lab, and championing women in life sciences.
Hiring more QA staff doesn't solve biotech compliance capacity problems — it masks them. Learn why compliance complexity outpaces headcount, and what a continuous compliance execution model actually looks like.
Most biotech QA teams aren't short on people, they're short on capacity. Learn where the hours actually go, and what it's costing your clinical program.
Fragmentation in biotech compliance does not announce itself. It accumulates quietly, buried in normal operations and unseen until it disrupts.
Your biotech compliance model is passing audits. That's not the same as being ready for what's next. Here's when and why manual models quietly break.
Move beyond checkbox compliance. Explore expert insights on QMSR, proactive supplier management, and building a continuous quality management system.
Looking for the top life science conferences in 2026? Check out our curated list of industry events for pharma, med device and biotech professionals.
Don't let an ISO audit scare you. Learn from these mistakes so you can prepare and pass an ISO audit this year.
Digging for venture capital funding for your medical device company this year? Learn our 5 secrets for maximizing your chance of success.
Explore the best document control software for life sciences. Read reviews about the best document version control software.
21 CFR Part 11 governs electronic records & electronic signatures. Learn what medical device manufacturers must know about 21 CFR Part 11 to be compliant.
Get a comprehensive understanding of the CAPA quality process. Learn how to identify root causes of compliance issues and avoid mistakes.
Learn how to write effective CAPA reports with our guide. Discover templates, examples, and essential tips for corrective and preventive actions.
Discover the top advantages of CAPA system software in 2024 and find the best solutions to enhance your quality management processes.
FDA Form 483 data throws a handy spotlight on the most common quality issues medical device companies run into. We looked at the top 4 - and how to avoid them.
Learn about the 7 best online quality management training courses can help your life sciences companies
Review the scope of quality assurance in the pharmaceutical industry, including responsibilities and expectations of pharma QA teams.
Learn the key steps of the FDA's Pre-Market Approval (PMA) submission process and the different types of PMA applications for your medical device.
FDA 21 CFR Part 11 compliance is a crucial requirement for regulated companies. Learn how to comply by giving yourself airtight control of your electronic records and signatures.
What is Current Good Manufacturing Practice (cGMP)? Why is it so important for pharma organizations? We interviewed 7 industry experts for the lowdown.
Where are US medical device companies going wrong with their 21 CFR 820 compliance? Form 483 inspectional observations reveal the most common non-conformance triggers.
These 4 free ISO 13485 audit checklists will help you achieve ISO 13485 compliance, prepare for certification and pass an audit.
Learn what a Design History File is and why it's important, the contents of a DHF, and how to prepare your DHF for an FDA Audit.
Explore the fundamentals of GxP in the modern life science environment and learn how to maintain compliance with GxP standards.
With the right medical device quality management system template, you can quickly produce a market-leading device. Use these 8 templates to get started.
FDA audits are a part of running a life sciences company. These 5 FDA audit preparation tips will improve your readiness and make things easier for your team.