NMCG President & Principal Consultant, Michael Nilo, will join Greenlight Guru for this AMA session of The Future of MedTech Virtual Summit to help decode major regulatory changes and what they mean for growing medtech companies. Attendees will leave with clear action steps and an understanding that flexible, audit-ready tools help teams stay compliant without heavy lifting.
Key topics:
- QMSR is coming: what’s new and how it aligns to ISO 13485
- AI/ML and SaMD: upcoming regulations and how to stay ahead
- Where most startups stumble on compliance (and how to avoid it)
- Tools that automate readiness without requiring massive headcount
- Ultralight as a low-lift way to stay aligned with evolving global regs
- Government shutdown: long term impacts
- AI in medtech
Greenlight Guru Virtual Summit - The Future of Medtech
November 19, 2025 | 9:00 am – 4:00 pm EST
For the innovators rewriting the rules of MedTech - this summit is your playbook.
Medtech is evolving faster than ever - with software-first design, AI-driven innovation, and tighter global regulations. Teams that adapt will define the next decade. This summit brings together the people, tools, and ideas helping them get there faster.
The virtual summit will offer two distinct tracks with 5 sessions each.
In the Premarket device track, you'll hear from operators, investors, and regulatory experts on how to:
- Stand up a quality system without slowing down
- Secure funding in a shifting capital environment
- Gather and leverage clinical data early
- Navigate changing global regulations
- Introduction to Ultralight, the modern eQMS for fast-moving innovators.
In the SiMD / SaMD track, we’re talking about:
- What a QMS should look like for software-first teams
- How to build audit-ready docs without hiring a full QA team
- How real startups are launching faster using modern tools
- A real-life case study on modernizing your quality management
- Introduction to Ultralight: the modern eQMS for software-enabled medtech teams
Whether you're in early product development or gearing up for submission, this summit is built to help you move faster without compromising compliance.