FDA QMSR Transition: What It Means for Your Future in Global MedTech

A strategic discussion with experts from DQS and Seratos on aligning with the FDA’s new rule — and what it unlocks for future growth.

The FDA’s new Quality Management System Regulation (QMSR) rule is more than a compliance update — it’s a global signal.

As the US aligns with ISO 13485, forward-thinking MedTech companies are rethinking how they operate, compete, and grow in international markets. Are you?

Join this hour-long, expert-led session to learn:

▪ What the QMSR actually changes — and what stays the same.

▪ How QMSR should reshape your global quality and regulatory strategy.

▪ What leading manufacturers are doing to stay ahead of the transition.

▪ When this shift will unlock faster market access

▪ The impact of QMSR on long-term operational efficiency

medical-product-home-dqs-medical instruments during a roentgen scan

Speakers:

Yuan Li, Director Medical Business of North America at DQS, Notified Body

Daniele Grondines, Client Engagement Lead - Medical Device & Regulatory Expert at Seratos Consulting, Management Consulting Firm

Who is this session for?

RA/QA leaders, quality managers, and MedTech executives who want to do more than check the box — and use QMSR as a strategic advantage.

Don’t miss this opportunity to stay ahead of the curve.

About our partner:

Seratos Consulting Inc. is a management consulting firm supporting organizations across industries — including medical technology, advanced manufacturing, software & digital technologies, engineering services, and legal & professional services.

“We deliver tailored, practical support — from gap analyses and risk assessments to implementation, internal audits, and certification preparation. Our expertise spans ISO 13485, ISO 9001, ISO/IEC 27001, and applicable FDA, Health Canada, and EU regulations.

With a client-first mindset, Seratos goes beyond compliance to serve as a trusted advisor in system maturity, global market access, and sustainable operational improvement.”

Timing is everything. Get your global regulatory framework into the development cycle as early as possible. That will allow you to leverage predicate devices, satisfy regulatory requirements and strengthen your design verification testing, including that of clinical studies.”

Yuan Li Director of Medical Business at DQS