When to implement a QMS guidance for MedTech startups

In the fast-paced world of Medical Technology (MedTech) startups, understanding when to implement a Quality Management System (QMS) is crucial for success. This masterclass will provide 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:
1. 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.

2. Timing Perspective: Learn strategic insights into when to initiate the formal development of your devices and start collecting data to support regulatory submissions effectively.

3. 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.

4. 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.

About Axel Strombergsson:
Axel Strombergsson brings a wealth of experience to this masterclass, blending his strong R&D background with deep expertise in startup strategies and commercialization. With a passion for driving health innovation forward, Axel’s insights will empower attendees to navigate the complexities of QMS implementation with confidence.

LinkedIn: https://www.linkedin.com/in/axel-strombergsson/
Veeva Systems: https://www.veeva.com/
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About InnovatorMD:

Change is happening everywhere in healthcare!

Although physicians are considered the scientific leaders in healthcare, they are not seen as the ones pushing for change and improvement. Physicians have been delegated to be figureheads and accept change as it happens to them. We have seen physician innovators working on some amazing things in different areas around the world.

The role of InnovatorMD is an attempt to showcase their work, inspire others to learn, and ignite innovation in healthcare.

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