Medical Device Regulatory and Quality Management Do's and Don'ts

This AMA session will provide startup medical product companies within the M2D2 Center an

opportunity to engage with regulatory, clinical, quality, insurance reimbursement, and cybersecurity

experts. The discussion will focus on essential compliance and market access strategies that startups

must navigate to bring their innovations to market successfully.

1. Clarify Regulatory Pathways – Understanding FDA, EU MDR/IVDR, and other global regulatory

requirements.

2. Discuss Clinical Evidence Strategies – When and how to conduct clinical trials, data collection,

and submission requirements.

3. Ensure Product Quality & Compliance – Best practices for Quality Management Systems (QMS)

and risk mitigation.

4. Explore Insurance Reimbursement Challenges – Coding, coverage, and payment strategies for

new medical technologies.

5. Understand Cybersecurity Regulations – How to ensure compliance with evolving cybersecurity

requirements for connected medical devices.

12:00 PM – 12:10 PM | Welcome & Introduction

• Opening remarks from Barry Sands, Founder and President, RQMIS, Inc.

• Brief introduction to RQMIS and its expertise in regulatory, clinical, quality, insurance

reimbursement, and cybersecurity for medical startups.

• Overview of session format: interactive Q&A with live and pre-submitted questions.

12:10 PM – 12:15 PM | The Landscape for Medical Product Startups

• Overview of key regulatory, clinical, quality, and insurance reimbursement hurdles facing

startups.

• The importance of early compliance planning for market success.

12:15 PM – 1:15 PM | Live AMA Discussion

💬 Open Q&A Session – Audience-Driven Discussion

RQMIS Ask Me Anything (AMA) Session Plan

• Attendees will have the opportunity to ask questions in real time.

• Moderated discussion covering:

o FDA & EU regulatory submissions (510(k), De Novo, PMA, MDR/IVDR).

o Clinical study requirements and ethical considerations.

o Implementing an effective Quality Management System (ISO 13485, FDA QSR).

o Navigating insurance reimbursement challenges (Medicare, private payers).

o Cybersecurity requirements and FDA expectations for connected medical devices.

1:15 PM – 1:25 PM | Key Takeaways & Closing Thoughts

• Recap of key insights shared during the discussion.

• Encouragement for startups to engage with experts early in their product development.

1:25 PM – 1:30 PM | Networking & Informal Discussion

• Opportunity for attendees to connect with the RQMIS team and schedule follow-up

conversations.

Our mission is simple: Get our clients' products to market, and keep them there.

Since 1996, RQMIS (Regulatory/Quality Management Information Source) has been a trusted partner for companies navigating the complex regulatory landscapes of the medical device, pharmaceutical, nutraceutical, and cosmetic industries worldwide. With offices strategically located in Boston, USA; Barcelona, Spain; and London, UK, we are well-positioned to support our clients' global commercialization efforts.

Our team is led by a former FDA reviewer from the Office of Device Evaluation, Boston district, bringing invaluable regulatory insight to our clients. We specialize in:

• Regulatory Strategy and Submissions
• Clinical Study Design and Management
• Quality Systems Design and Compliance
• Insurance Reimbursement
• Postmarket Surveillance
• Cybersecurity

Operating as a family business, we prioritize personalized service, ensuring accessibility and responsiveness to our clients' needs. Our goal is to execute the most efficient and cost-effective commercialization pathways, acting as a comprehensive "one-stop-shop" for regulatory, quality, and clinical solutions.

Our diverse team boasts expertise in areas such as Software as a Medical Device (SaMD), artificial intelligence, cardiology, orthopedics, Ph*rm*cy, cosmetics, and nutrition, enabling us to provide specialized knowledge tailored to each client's unique challenges.

At RQMIS, we are committed to guiding your products to market and ensuring they remain there, adhering to the highest standards of safety and efficacy.

Host or Publisher M2D2