San Francisco Bay Area Chapter In Person Event: Regulatory Considerations for Start-up Companies

When:  Dec 10, 2025 from 17:30 to 20:00 (ET)

Working as a regulatory professional in a start-up or small company can be a challenging experience. While all companies have limited resources and budgets, start-ups often face situations where their success depends on launching a medical device or diagnostic quickly and within a tight budget.

Start-up teams may lack a background in medical devices or diagnostics and may not fully appreciate the value of regulatory affairs. Engaging with regulatory matters early and developing a strong regulatory strategy are essential for obtaining timely marketing approvals.

Stakeholder management and the ability to build and maintain an effective network are also crucial, particularly in organizations that rely on external partners.

The goal of this presentation is to share strategies for addressing these challenges.

Registration Fees & Deadlines

Member $15 | Nonmember $25

Learning Objectives

Strategies for effective stakeholder management and networking:
Participants will discover practical approaches for managing internal and external stakeholders and building an effective network, recognizing their importance for success in regulatory affairs, particularly in organizations with limited budgets and resources.

The importance of early regulatory engagement:
Participants will be able to articulate why early engagement in regulatory affairs is critical for the development of a medical device or diagnostic.

Key components of a robust regulatory strategy:
Participants will be able to identify the essential elements of a successful regulatory strategy.

Agenda

5:30-5:50 pm Check-in/Networking
5:50-6:00 pm RAPS-SF and Sponsor Introduction
6:00-7:00 pm Presentation(s)
Panel Discussion/Q&As
7:00-8:00 pm Networking and Wrap-up

Speaker

Heinz Steneberg
President & CEO, MDSS

Qing Zhang, MD MBA
Partner, LDV Partners

Location

Fogarty Innovation
Sobrato Pavilion
2495 Hospital Drive
Suite 300
Mountain View, California 94040

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.orgCancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

Location

2495 Hospital Dr
Sobrato Pavilion Ste 300
Mountain View, CA 94040-4119