Events

2026

RMRAS Annual FDA Update
Thursday, September 3, 2026
4:00 pm - 7:30 pm
PPA Event Center
2105 Decatur, Denver, CO 80211

 For more than 15 years, the Rocky Mountain Regulatory Affairs Society (RMRAS) has proudly presented the Annual FDA Update—our premier event and one of the most anticipated programs of the year. Since 2009, this event has provided a unique opportunity for professionals across the medical device, pharmaceutical, biotechnology, and life sciences industries to hear directly from representatives of the FDA's Denver District.

The Annual FDA Update has become a cornerstone event for our regional community. We are thrilled to bring this outstanding program back in 2026 and invite you to join us this September for an evening of valuable insights, professional development, and exceptional networking opportunities.

The FDA Panel includes:
E. Mark Harris
Acting Office Director
Office of Inspections and Investigations
Food Products Inspectorate, Office of Human Food Inspectorate West
Topic: Short welcome, local management and current organization/
 
Bryan J. Love               
Special Assistant, OMDRHI
Topic: QMSR Implementation and Current Update to Compliance Program Inspection of Medical Device Manufacturers
 
Matthew M. Vernon, PhD (BME)
Medical Device Specialist, OMDRHI
Topic: Commonly Encountered FDA-483 Citations to Identify Before FDA Arrives
 
Audrey Vigil
Division Director, Office of Bioresearch Monitoring, OII
Topic: 

Schedule:

4:00 – 4:30    Registration 
4:30 – 6:00    Presentation by FDA Panel                      
6:00 – 7:30    Networking with hors d'oeuvres and a cash bar

Sponsors:
On behalf of the Rocky Mountain Regulatory Affairs Society (RMRAS), we extend our sincere gratitude to our sponsors for their generous support.  We truly appreciate your commitment to our organization and to advancing professional education within our industry.  

AlloSource is a life sciences organization that helps restore patient functionality by transforming the gift of human tissue donation into enhanced medical products that enable a life of movement, health, and wellbeing. We partner with medical professionals and biomedical companies who share our drive for innovation and quality in the use of human tissue allografts for medical advancements. Headquartered in Centennial, Colorado, we have served a global marketplace since 1994. Learn more at allosource.org.

Flagship Biosciences has been at the forefront of spatial biology, digital pathology, and quantitative tissue analysis since 2009. With a focus on advancing precision medicine and improving patient outcomes, Flagship utilizes cutting-edge technology and innovative approaches to analyze tissue samples with unparalleled accuracy and efficiency. We provide valuable insights from complex tissue data, enabling clients to make informed decisions in drug development, clinical trials, and patient care.  Our comprehensive suite of services includes tissue image analysis, biomarker discovery, and companion diagnostic development, all tailored to meet the diverse needs of pharmaceutical, biotechnology, and academic research organizations.

LivaNova has been offering customer-centric perfusion and cardiopulmonary solutions for over 50 years. A complete range of cardiopulmonary equipment and disposable products are used to treat millions of patients worldwide. Our newest innovation, Essenz Perfusion System, combines the state-of-the-art Essenz heart-lung machine with an intuitive patient monitor and accurate sensing technology, enabling data-driven decision making.

Polaris Biomedical, LLC provides quality engineering, regulatory strategy, systems engineering, and product development consulting for medical device and biotechnology companies. We support organizations throughout the product lifecycle, from early-stage development and regulatory strategy through quality system implementation, design controls, risk management, regulatory submissions, audits, and post-market compliance. Our practical, cross-functional approach helps companies navigate complex requirements, strengthen their operations, and bring safe, effective, and compliant medical technologies to market.

Terumo Blood and Cell Technologies is a medical technology company. Our products, software and services enable customers to collect and prepare blood and cells to help treat challenging diseases and conditions. Our employees worldwide believe in the potential of blood and cells to do even more for patients than they do today. This belief inspires our innovation and strengthens our collaboration with customers. Terumo Blood and Cell Technologies' customers are based in over 160 countries. Terumo Blood and Cell Technologies is a subsidiary of Terumo Corporation (TSE: 4543), a global leader in medical technology.

Vitalant is one of the nation’s largest nonprofit blood and biotherapies healthcare organizations, providing lifesaving blood products and services to approximately 900 hospitals nationwide. Through specialized laboratory services, transfusion medicine expertise, biotherapies capabilities and internationally recognized research, Vitalant advances the science, safety and practice of transfusion medicine and patient care.

This event is complementary and open to all interested professionals. While there is no cost to attend, we kindly ask that you register in advance so we can plan appropriately for seating, refreshments, and networking accommodations. Your registration is greatly appreciated and helps us ensure an enjoyable experience for all attendees. We look forward to seeing you in September!

To RSVP, go to programs@rmras.org

For questions or additional information, contact Nan Matthews, programs@rmras.org or 303-843-6414.

This course provides an overview of the U.S. FDA 510(k) Premarket Notification process, the most common regulatory pathway used to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. Participants will gain a practical understanding of regulatory requirements, submission components, performance testing expectations, and strategies for preparing a successful 510(k) submission using the eSTAR system. The course is designed for regulatory affairs professionals, quality professionals, product developers, engineers, and project managers involved in medical device development and commercialization.

Learning Objectives

By the end of this course, participants will be able to:
1. Explain the FDA 510(k) Regulatory Framework
*Describe the purpose of the 510(k) process, device classifications, and the concept of substantial equivalence.
2. Identify Required Elements of a 510(k) Submission
*Recognize key submission components, including device descriptions, intended use statements, labeling, and supporting documentation.
3. Evaluate Testing and Evidence Requirements
*Determine appropriate performance including, biocompatibility, software, electrical safety, and clinical testing requirements based on device risk and characteristics.
4. Develop a 510(k) Strategy
*Select suitable predicate devices, assess regulatory risks, and create a submission plan that supports timely FDA review and clearance.
5. Have familiarity with the FDA 510(k) eSTAR template and submission process.
 

TO REGISTER, GO TO  

https://cvent.me/meEwAD?RefId=HSNGWGLT3G2

For questions, contact Nan Matthews, 303-843-6414 or Email BEFORE starting your group registration in order to enter the information correctly.

Topic Ideas?

Please send us your ideas for meeting topics, programs, classes, etc. Email info@rmras.org.