Mobilizing the right balance of industry expertise and practical solutions to deliver unparalleled results.

Medical Devices

Pharmaceuticals

Combination Products

Biologics

Who We Are.

Trusted. Proven. Chosen.

With 20+ years of proven success and a roster of returning clients, QualityHub isn’t just experienced – we are experience, built on trust, results, and lasting relationships. We transform goals into outcomes and foster bonds that stand the test of time.

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On-Demand Talent
for the Lifecycle of
Your Regulated Product.

Talent Categories
Product Development/R&D Quality Assurance Regulatory Affairs Manufacturing & Operations Supply Chain Clinical Program/Project Management

Product Development/R&D

When projects pile up and timelines tighten, QualityHub delivers product development and R&D professionals who keep things moving. Our experts plug in fast, bring fresh perspectives, and drive progress without missing a beat.

> Find out how QualityHub has your staffing needs covered for product development and R&D.

Quality Assurance

Need sharp, reliable QA talent – right now? QualityHub connects you with experienced Quality Assurance experts who hit the ground running. From audit prep to process validation, our professionals keep your quality system compliant, efficient, and stress-free.

> Find out how QualityHub has your QA staffing needs covered.

Regulatory Affairs

Regulatory challenges move fast, so make sure your team moves faster. QualityHub matches your company with longtime Regulatory Affairs pros who seamlessly integrate, tackle complex requirements, and keep your projects on track.

> Find out how QualityHub has your RA staffing needs covered.

Manufacturing & Operations

Need skilled manufacturing and operations experts who are ready on Day One? QualityHub delivers top-tier talent fast so you never miss a beat. Whether it’s ramping up production or creatively handling unexpected demands, our experts keep things running smoothly.

> Find out how QualityHub has your staffing needs covered for manufacturing and operations.

Supply Chain

Power your supply chain with seasoned experts who know the ropes and the regulations. At QualityHub, we connect you with top-tier professionals who don’t just understand supply chain challenges – they bring risk management, contingency plans, and resilience.

> Find out how QualityHub has staffing needs covered for your supply chain.

Clinical

QualityHub’s clinical pros understand regulated industry’s need for rigorous clinical data. Our carefully vetted professionals ensure compliance with requirements, appropriate study design, and clear interpretation of results, giving your company market authorization confidence and the highest standards of product quality and safety.

> Find out how QualityHub has your clinical staffing needs covered.

Program/Project Management

QualityHub experts bring clarity, compliance mastery, and relentless focus to the management of your regulated company’s programs and projects. They streamline workflows, minimize risks, and keep initiatives advancing and on target.

> Find out how QualityHub has your staffing needs covered for program and project management.

What Our Clients Say About Us.

"The FDA readiness training was tailored to our specific manufacturing site and incorporated local procedures and previous regulatory comments. This targeted approach yielded a greater training impact and understanding."
"The training we received from QualityHub FDA compliance consultants was invaluable in preparing the site for an inspection. This helped establish proper expectations and confidence. QualityHub provided excellent screening, guidance and training for the establishment of the staging room operations, scribes and inspection administrators."
"QualityHub's input in regard to inspection readiness has been very helpful in preparation for that success!"
"The FDA readiness training by QualityHub is a great refresher course. Take the time to polish up and improve your preparedness knowing their knowledge and expertise makes this a worthwhile practice."
"Thanks to QualityHub's input and the mock inspection, our improved tactics and inspection readiness activities really paid off."

Explore Our MediaHub

QMSR Insights: 6 Red Flags Your MedTech Company Lacks Quality Culture

The FDA’s new Quality Management System Regulation makes quality culture a top management responsibility, and regulators will increasingly look for objective evidence that quality is embedded across MedTech organizations. In this QHub Insights piece, six red flags are highlighted – ranging from poor employee engagement and weak training to misaligned incentives, and the absence of systemic risk management – that signal a deficient quality culture. PLUS: Best practices companies can use to demonstrate a genuine, sustainable commitment to quality under the QMSR.

Life Sciences Comes Full Circle for Logan Thompson, QualityHub’s New CFO

Logan Thompson has been appointed the first Chief Financial Officer of QualityHub, bringing nearly 20 years of experience to the leading regulatory and quality consultancy for MedTech, pharma, and biologics. Thompson aims to combine strategic financial leadership with operational efficiency to help clients navigate compliance, drive growth, and maximize profitability.

QMSR Insights: 6 Red Flags Your MedTech Company Lacks Quality Culture

The FDA’s new Quality Management System Regulation makes quality culture a top management responsibility, and regulators will increasingly look for objective evidence that quality is embedded across MedTech organizations. In this QHub Insights piece, six red flags are highlighted – ranging from poor employee engagement and weak training to misaligned incentives, and the absence of systemic risk management – that signal a deficient quality culture. PLUS: Best practices companies can use to demonstrate a genuine, sustainable commitment to quality under the QMSR.

Life Sciences Comes Full Circle for Logan Thompson, QualityHub’s New CFO

Logan Thompson has been appointed the first Chief Financial Officer of QualityHub, bringing nearly 20 years of experience to the leading regulatory and quality consultancy for MedTech, pharma, and biologics. Thompson aims to combine strategic financial leadership with operational efficiency to help clients navigate compliance, drive growth, and maximize profitability.

MDSAP Approach Updated for FDA’s QMSR, Predetermined Change Control Plans

The IMDRF has revised its MDSAP audit approach to align with the FDA’s new Quality Management System Regulation, removing references to the former QSR rule and reinforcing closer alignment with ISO 13485. Key updates include greater transparency for agency investigators into audit reports and management reviews, increased emphasis on lifecycle risk management, and new guidance on auditing FDA Predetermined Change Control Plans (PCCP), particularly for AI-enabled medical devices.

QMSR Insights: From Assessing FDA’s Inspections CPM to Enhancing Supplier Oversight, Here’s 7 Things MedTechs Should Do Right Now

The FDA’s Quality Management System Regulation is now in effect, requiring medical device companies to transition from the legacy QSR rule to a framework aligned with ISO 13485 while meeting agency-specific expectations. To ensure a smooth transition, manufacturers should, among other things, engage executive leadership, update procedures and training, conduct gap analyses, strengthen supplier oversight, and prepare for FDA inspections using the agency’s new Compliance Program Manual, QualityHub experts say.

R.I.P. QSIT (1999-2026): A Requiem for FDA’s Inspection Technique

As the FDA prepares to retire its longstanding Quality System Inspection Technique with the rollout of the new Quality Management System Regulation, QSIT creator and QualityHub President Tim Wells reflects on the tool’s origins, impact, and legacy. Developed in the late 1990s to make medical device inspections more efficient and consistent, QSIT not only improved FDA oversight but was widely adopted by industry as a self-audit framework that strengthened quality systems and patient safety.

QMSR’s Design & Development: 7 Questions Answered By FDA

The FDA’s Quality Management System Regulation, effective Feb. 2, replaces the agency's traditional Design Controls with ISO 13485–aligned Design and Development activities, marking a significant shift for medical device manufacturers. The FDA outlined expectations and answered industry questions on these changes during a Jan. 14 Town Hall webinar.

Risk Management & QMSR: 7 Questions Answered By FDA

With the FDA’s Quality Management System Regulation coming into force on Feb. 2, medical device makers face heightened pressure to strengthen risk management practices as the agency aligns its legacy Quality System Regulation with ISO 13485. During a Jan. 14 FDA Town Hall, agency officials addressed industry questions on risk management expectations under the new QMSR.

🔥 QMSR: FDA Answers 21 Burning Questions From MedTechs

Five FDA officials answer questions from medical device manufacturers about the agency's Quality Management System Regulation, or QMSR, which goes into force for industry on Feb. 2.

A ‘Major Change’: Is Your MedTech Company Ready for FDA’s Review of Audit Reports?

The FDA’s new Quality Management System Regulation, effective Feb. 2, will allow the agency to review a medical device manufacturer's internal and supplier audit findings for the first time, marking a significant shift in inspection expectations. Industry attorneys warn companies must ensure audit issues are clearly documented, addressed through CAPAs when necessary, and integrated into quality systems to withstand increased regulatory scrutiny.