Are you ready for the FDA's Quality Management System Regulation (QMSR) transition?
The FDA’s new QMSR is set to become effective in February 2026. As a complex regulatory change, it requires careful planning and execution to ensure compliance. Don’t wait — get started now!
Why Choose AlvaMed?
Our team of experienced quality and regulatory experts is dedicated to guiding you through the QMSR transition process to help you:
- Understand the QMSR requirements: Our experts will provide in-depth analysis of the new regulations, highlighting key changes and potential impact on your organization.
- Assess current QMS: We will conduct a thorough evaluation of your existing Quality Management System (QMS) to identify gaps and areas for improvement.
- Develop a transition plan: Our team will work with you to create a customized transition plan, outlining specific steps, timelines, and resource allocation.
- Implement QMS enhancements: We will provide practical guidance on implementing necessary changes to your QMS.
- Prepare for FDA inspections: Our experts can help you prepare for FDA inspections by conducting mock audits and providing training on inspection readiness if desired.
How You Can Benefit from Partnering with AlvaMed:
- Minimized disruptions: Our streamlined approach will help minimize disruptions to your operations.
- Reduced compliance risks: Our expert guidance will help mitigate compliance risks and avoid potential pitfalls.
- Customer focus: We are committed to delivering customized solutions that are right sized for each customer’s unique needs.
Don’t Let the QMSR Transition Overwhelm You.
Partner with AlvaMed to transition to QMSR with confidence.
Jon Saltonstall is Senior Vice President of Regulatory and Quality Compliance at AlvaMed. Jon has many years of practical experience implementing and maintaining right-sized QMS solutions for startups and small companies.
