The shift from QSR to QMSR represents the most significant change to medical device regulation in decades. In 2026, the FDA is no longer looking for a trail of paperwork; they are looking for evidence of a living, breathing and risk-integrated system. This shift moves the industry from documentation-based compliance to a model where ISO 14971 risk management must be woven into every thread of the organization.
The challenge? Most legacy systems aren’t built for this level of integration. When your risk data lives in a vacuum, your QMS becomes a liability during an inspection. Under the new QMSR framework, investigators are prioritizing “systemic effectiveness.” If your change controls, CAPAs and supplier audits aren’t talking to each other through a centralized, precise data layer, your organization is vulnerable.
At AVS Life Sciences, we believe this transition is an opportunity to move from a reactive posture to a digitally enabled one. “AI-level precision” isn’t about replacing human expertise. It’s about augmenting it to ensure that no risk goes unquantified and no data point is left isolated. By automating the heavy lifting of traceability and impact analysis, you can ensure that your team is always audit-ready, even as regulatory expectations continue to evolve.
In this webinar, AVS Life Sciences’ subject matter experts will break down the “must-haves” for 2026. We will explore how to bridge the gap between ISO expectations and FDA enforcement, and why digital precision is the only way to maintain compliance at scale. Register Now and Secure Your Spot.
Speakers
Mandy Gervasio
Mandy Gervasio is an Enterprise Quality and Risk Executive with more than 20 years of experience across biotech, pharmaceutical and medtech organizations. She is known for building and evolving quality systems that work in practice, supporting both regulatory expectations and the realities of how organizations operate and scale.
Her approach is grounded in designing fit-for-purpose systems that bring clarity, accountability and better decision-making into day-to-day operations. She focuses on connecting quality, risk and data in a way that makes governance more effective and less reactive, particularly in complex, outsourced environments.
Mandy has held senior leadership roles across sponsor and CDMO organizations, where she built quality infrastructure from the ground up and established governance across global partners and supply networks. Her experience includes commercial readiness, combination product oversight and leading global audit and inspection programs.
She works closely with executive teams to translate regulatory complexity into practical, risk-based approaches that support growth, resilience and performance. Mandy is the creator of the Automating Quality podcast and a frequent speaker on quality transformation and the evolving role of AI in regulated environments.
Message Presenter
Lauren Mermelstein
Lauren Mermelstein is a Quality Assurance professional with over a decade of experience in the pharmaceutical and biotechnology industries, specializing in GxP compliance, data integrity and inspection readiness. She has supported quality oversight across GMP manufacturing and laboratory operations, with a strong focus on risk-based decision-making and navigating evolving regulatory expectations.
With experience working at the intersection of development and compliance, Lauren brings a pragmatic and forward-looking perspective to QMSR implementation, helping bridge traditional GMP frameworks with the evolving expectations of the medtech regulatory landscape.
Message Presenter
Divya Gowdar
Divya Gowdar is a performance-driven leader with a proven track record of achievements and extensive experience in medical devices and combination products. Exhibited significant contribution in quality management systems, product development lifecycle, risk management, quality compliance and technical operations. Exemplify sound judgment, decision making, critical thinking, problem-solving, analytical, negotiation and interpersonal skills that drive successful and positive results.
Message PresenterWho Should Attend?
This webinar is essential for cross-functional teams navigating the 2026 regulatory shift, including:
- Quality & Compliance Leaders: Moving from reactive documentation to risk-integrated QMSR frameworks
- Innovation & Digital Transformation Stakeholders: Implementing AI-level precision and data-driven quality systems
- Regulatory & Manufacturing Teams: Managing the harmonization of ISO 13485 and ISO 14971 into daily operations
- Emerging MedTech & Biotech Teams: Navigating speed, capital constraints and the complexity of the 2026 transition
What You Will Learn
Attendees will have a better understanding about the following:
- Validated digital systems aligned with 21 CFR Part 11 and GAMP 5
- Explicit integration of ISO 14971 risk management throughout the QMS lifecycle
- Reactive vs. Proactive Risk Models
- Why AVS Life Sciences is the leading of quality, regulatory, commissioning, qualification and validation (CQV) consulting services
Xtalks Partner
AVS Life Sciences
AVS Life Sciences provides end-to-end support for biotech, pharma, and medical device companies, guiding products from initial development through full-scale commercialization. With a legacy of over 30 years, our expert consulting services deliver integrated solutions across quality, regulatory affairs, clinical operations, manufacturing, and Commissioning, Qualification, and Validation (CQV). We empower manufacturers to navigate complex lifecycles with proven industry expertise and strategic operational oversight.
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