Preparing for QMSR inspections or navigating post-effective-date expectations?
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Meet Global Quality Expectations
Kymanox helps organizations operationalize QMSR across the product lifecycle, connecting leadership, systems, and execution into a single, defensible quality framework.
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Support for Your Next FDA Inspection and Beyond
Senior Director of Quality Control
Pharmaceutical Company
Kymanox has been a really solid partner for us. They’re knowledgeable, capable, and timely on their deliverables. They’ve helped us lay a good foundation with quality control and have been a solid partner in helping us grow.
FDA TOWN HALL KEY TAKEAWAYS
Quality Management System Regulation: Risk and Design and Development
The U.S. Food and Drug Administration (FDA) hosted a town hall for industry and other interested parties to discuss the Quality Management System Regulation (QMSR).
FDA Call to Action
- Continue building quality, safety, and effectiveness into every medical device
- Review and understand the QMSR requirements
- Strengthen risk management practices to support sound decision-making
- Ensure design and development activities meet all applicable requirements
Risk-based thinking must permeate the entire QMS
Risk-based approaches apply across functions including human resources, purchasing controls, nonconformances, CAPA, monitoring and measurement, production, servicing, calibration, and preventive maintenance. Different levels of risk require different levels of control and investigation.
Risk-based approach vs. risk-based decision-making
A risk-based approach involves identifying risks and opportunities to prevent or reduce undesired effects. Risk-based decision-making builds on this foundation to support sound, documented decisions—particularly during design and development.
Flexibility in risk management methods
QMSR does not mandate specific tools or the use of ISO 14971. Manufacturers may use validated, fit-for-purpose risk management methods, provided they are consistently applied and well documented.
Design controls remain central
Design reviews are required, but independent reviewers are not mandated. FDA values meaningful oversight by knowledgeable personnel. Design history files must be maintained throughout the product lifecycle, with change control governing updates.
Leadership and culture of quality matter
FDA clearly expects manufacturers to be led by executives who actively support and sustain an effective culture of quality—risk-based thinking starts at the top.
Transition and continuous improvement
Devices developed under the previous 21 CFR 820 will not require retroactive file remediation. However, FDA recommends performing a gap analysis against ISO 13485 to confirm alignment going forward. Customer feedback is part of post-market surveillance and should feed directly back into risk management activities.
What We Offer
Visit our quality and compliance services page to learn more about how we can support on your next milestone. Our team brings deep regulatory experience, including enhancing more than 100 quality management systems and supporting over 10 major inspections in the past five years. Explore how we help organizations strengthen quality culture, reduce risk, and prepare with confidence.
Quality Leadership
Our Quality Leadership and Operations Representative services provide flexible, expert-level support when and where you need it most. From fractional leadership to hands-on operational oversight, we act as an extension of your Quality Unit to ensure your products and processes meet the highest standards.
Quality Management System
Our team partners with clients to build sustainable Quality Management Systems (QMS) and support the underlying quality processes that align with global regulatory requirements and GxP standards while enabling ongoing innovation and operational efficiency.
Audits & Inspection Readiness
Comprehensive audit and inspection readiness is essential for life science organizations navigating regulatory requirements and operational complexities.
Quality Event Management
Quality event management is critical for life science companies to maintain compliance, safeguard patient safety, and avoid costly regulatory repercussions. Partnering with Kymanox means leveraging deep regulatory knowledge and experience managing thousands of quality events.
Quality Engineering
Our Quality Engineering team supports every stage of development and manufacturing, helping clients mitigate risks and achieve regulatory success.
Regulatory Support
Our Regulatory Affairs team helps clients navigate complex global requirements by developing regulatory strategies, preparing submissions, and supporting responses to enforcement actions to ensure products reach and remain on the market.