FREE ON-DEMAND WEBINAR
MedTech QMS Implementation: Understanding the Why, What, When, and How
In the fast-paced world of MedTech, understanding when to implement a Quality Management System (QMS) is crucial for startups to achieve success.
This masterclass, hosted by InnovatorMD and presented by Axel Strombergsson, provides actionable guidance on navigating the complexities of QMS implementation, ensuring that your submission to regulatory authorities like the FDA is complete and positioning your device for successful commercialization.
Key Topics Covered:
- Importance of QMS: Gain a comprehensive understanding of why a QMS is essential for MedTech startups, from ensuring regulatory compliance to enhancing product quality and patient safety.
- Timing Perspective: Learn strategic insights into when to initiate the formal development of your devices and start collecting data to support regulatory submissions effectively.
- Navigating Regulatory Requirements: Explore the regulatory landscape, including FDA submissions and compliance with other authorities, ensuring that your submission is thorough and meets all necessary criteria.
- Preparing for Commercialization: Discover how a well-implemented QMS can streamline processes, reduce time-to-market, and enhance market readiness, positioning your device for successful commercialization.
Your free download includes:
- On-Demand Webinar Recording
- Presentation Slide Deck
Access Webinar Resources!
About the Presenter
Axel Strombergsson, VP of QuickVault at Veeva Systems, Inc.
Axel brings over 20 years of diverse experience in the MedTech industry, spanning R&D leadership, operations, regulatory strategy, and medical device commercialization. Before joining Veeva, Axel led R&D efforts for a surgical device company and later transitioned to roles focused on scaling operations and bringing medical devices to market. He also worked at Vanderbilt University’s Tech Transfer Office, where he collaborated with research teams on cutting-edge medical device innovation.
As an integral part of multiple MedTech startups, Axel has gained firsthand experience in navigating the challenges and opportunities of the entire device lifecycle. Beyond his professional roles, Axel is a passionate mentor and thought leader within the MedTech ecosystems in both the US and EU. He frequently delivers lectures and provides mentorship to startups and smaller companies, helping them navigate regulatory landscapes and accelerate business growth.
With his extensive expertise and practical insights, Axel is uniquely positioned to guide companies in achieving success across R&D, regulatory compliance, commercialization, and long-term business development.
About QuickVault by Veeva
QuickVault by Veeva is the leading device-to-market solution for MedTech companies. Built for full device lifecycle support, the platform unifies design, regulatory, quality, and post-commercial operations in one scalable environment—helping teams stay agile, compliant, and ready to grow.
From concept through commercialization and beyond, QuickVault by Veeva gives MedTech companies the visibility and control they need to deliver safe, effective products to patients and succeed at every stage.