The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks the most significant update to 21 CFR Part 820 in nearly two decades. But for medical device manufacturers, this is more than just a regulatory rewrite—it is a shift toward global harmonization that requires immediate strategic action.

In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo, Senior Director of Quality at Kymanox, to unpack the practical realities of the QMSR rollout. With over 30 years of experience in quality systems and design controls, David explains why "being ISO 1345 certified" isn't a free pass for compliance and how to turn this regulatory hurdle into a long-term business advantage.

Topics Include:

• The "Why" Behind QMSR: Understanding the FDA's push to harmonize with ISO 1345:2016 and what it means for global market access.
• Risk Management Evolution: Moving beyond product risk (ISO 14971) to apply risk-based decision-making across the entire quality system, from CAPAs to training.
• The Certification Myth: Why your existing ISO 1345 certificate won't stop the FDA from auditing your facility.
• Supplier Controls: How to update supplier files to be "living documents" that satisfy the new monitoring requirements.
• A 5-Step Implementation Roadmap: A proven strategy to assess gaps, remediate SOPs, and ensure your team is ready before the deadline.

Whether you are a VP of Quality or a Regulatory Affairs specialist, this conversation offers a clear, science-forward path to navigating the new landscape of medtech compliance.

📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.

Developing complex biologics and advanced therapies is historically time-consuming and material-intensive—but computational modeling is reshaping the formulation landscape.

In this episode of Life Science Solutions, host Chris Adkins is joined by Andrea Arsiccio, PhD, Senior Scientist and Team Lead In Silico at Coriolis Pharma, to discuss how in silico modeling is revolutionizing the assessment of developability and formulation strategies for new drug products.

Andrea breaks down how Coriolis Pharma combines physics-based models and Artificial Intelligence with traditional wet lab experimentation to predict molecule behavior, identify liabilities early, and solve complex problems like aggregation and viscosity.

Topics Include:

• Defining In Silico: Understanding the spectrum from mechanistic models and molecular dynamics to AI and machine learning.
• Accelerating Development: How computational tools reduce the need for animal testing and save precious material in early-phase development.
• The "Why" Behind the "What": Using modeling to uncover the specific mechanisms causing instability or aggregation.
• The Hybrid Approach: Validating digital predictions with high-throughput wet lab screening for a robust formulation strategy.
• Regulatory Perspectives: How the FDA and EMA are viewing AI data and the importance of establishing model credibility.
• Expansion: Coriolis Pharma’s growth into the US market and their new capabilities in Research Triangle Park.

Whether you are a formulation scientist, a CMC leader, or a regulatory professional, this episode provides a fascinating look at how digital twins and computational strategies are de-risking the path to market for life-saving therapies.

📍Recorded at Kymanox HQ in Research Triangle Park, North Carolina.

#Biologics #InSilico #DrugDevelopment #FormulationScience #AIinPharma #CoriolisPharma #LifeSciences #Kymanox

Design controls have long been the backbone of safe, compliant medical device development - but artificial intelligence is changing how teams manage them.

In this episode of Life Science Solutions, host Chris Adkins sits down with Nick Ciccarelli, Chief Technology Officer at Kymanox, to explore how AI is transforming design controls, the structured processes that ensure medical devices meet regulatory standards.

Nick shares practical examples of AI in action today, including analyzing large datasets during design verification and scanning FDA communications for emerging regulatory patterns.

Topics Include:

• What design controls are and why they matter for medical devices and combination products.
• How AI is evolving from a personal tool to a professional asset in regulated environments.
• Practical applications: analyzing FDA trends, summarizing post-market data, and streamlining documentation.
• Specific uses within Design Verification, including sample size determination and data analysis.
• Managing AI risks: why "hallucinations" happen and the need for expert human oversight.
• Sustainability considerations: could AI use impact environmental goals in MedTech?

Whether you’re a MedTech engineer, quality professional, or regulatory strategist, this conversation offers a roadmap for integrating AI safely and effectively into your design control process.

📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.
#MedTech #AI #DesignControls #MedicalDevices #RegulatoryScience #LifeSciences