September 18-19, 2025 | San Francisco Airport Marriott Waterfront

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JOIN US Why you should attend

The MPO Summit is a networking and educational event, bringing local experts together with out-of-state industry thought leaders.

Content To Expand Your Mind
Contacts To Grow Your Business

Networking

Built-in times allow for attendees from across the medical device manufacturing industry to meet with representatives from OEMs, suppliers, contract manufacturers, consultants, investors, and others.

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Attendees

The attendance make-up of those at the MPO Summit are typically mid- to upper-level management from medical device OEMs, suppliers, CMOs, and others aligned with the industry.

3

Agenda

A comprehensive agenda tackles a variety of critical topics focused on the medical device manufacturing industry, addressing current trends, issues, challenges, and concerns.

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Intimate Event

The singularly focused, boutique-style MPO Summit provides an environment for in-depth discussions about issues of most relevance to those involved with the development and manufacture of medical devices.

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GAIN CRITICAL INSIGHTS

Keep up-to-date on important topics impacting the medtech industry!

The MPO Summit is an annual event, focusing exclusively on the constant changes occurring within the medical device manufacturing industry.

AGENDA DETAILS Information of Event Schedule

The MPO Summit is please to provide the following agenda for our next event. Details will be added as they are finalized.

7:00-8:40 a.m.

Registration & Continental Breakfast

Sponsored by:

8:40-8:45 a.m.
speaker-1

Howard Revitch

speaker-2

Sean Fenske

Opening Remarks

8:45-9:00 a.m.

Welcome to Silicon Valley

An introduction of the region serving as the host of the 2025 MPO Summit—Silicon Valley—and an overview of why the area is important to the medical device manufacturing industry.

7:30-9:00 a.m.

Registration & Continental Breakfast

Sponsored by:

9:00-9:45 a.m.
speaker-1

Christopher Joseph Devine

FDA's New QMSR Is on the Horizon—Will Your Company Be Ready?

On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.” Considering 21 CFR 820 has been the agency’s standard for multiple decades, what is the impact of this alignment with ISO 13485:2016 and how will FDA implement and enforce compliance? The drop-dead date for compliance has been slated for February 2, 2026; and medtech companies (globally) will be expected to comply with the changes. This presentation will dive into: (a) the nuances of the FDA’s changes; (b) edits made to 21 CFR, Part 4 (clarification for combination products); (c) FDA’s development of a new inspection process that better aligns with ISO 13485 requirements; (d) requirements/expectations for compliance; and (e) future changes made to ISO 13485.

9:45-10:30 a.m

Session 9

Description to come.

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