Building the Right QMS at the Right Time: A Practical Guide for MedTech Startups

For an early-stage MedTech company, implementing a QMS does not have to mean introducing a complex set of processes all at once. The key is understanding which parts of the quality system are needed, when they should be introduced, and how to build them into the business without creating unnecessary burden.

In this session, Axel Strombergsson, VP of QuickVault at Veeva and a MedTech leader with more than 20 years of hands-on industry experience, will provide practical guidance for developing a QMS that supports each stage of the medical device lifecycle.

This session will explore:

• Why a QMS creates value beyond meeting regulatory requirements
• What processes, technology, training, and expertise form the foundation of an effective QMS
• When early-stage companies should implement design controls, risk management, supplier management, and other key processes
• How to expand the QMS as the company approaches commercialization
• How strong quality practices can reduce development risk and support fundraising, due diligence, and future acquisition

Attendees will learn how to take a focused, stage-based approach that keeps the organization lean while establishing the compliance, traceability, and operational foundation needed to bring a medical device to market and support its continued growth.