Advance the understanding and practice of worldwide medical Regualtory Affairs for members in the Rocky Mountain region.
Daniel Simpson, RAC (US, CAN), ASQ CBA. - President
Senior Director, Clinical and Regullatory Affairs, Corgenix
Mr. Simpson is currently the Senior Director of Clinical and Regulatory Affairs at Corgenix Inc. which produces In Vitro Diagnostic (IVD) products for the clinical laboratory market as a part of the ORGENTEC Group of companies. Mr. Simpson currently is in charge of all clinical and regulatory activity for the company’s current product portfolio. Additionally, Corgenix offers contract development, clinical, regulatory, and commercialization activities for companies that have research diagnostic products for which they are seeking regulatory authorization as an IVD. In this capacity, Mr. Simpson has developed regulatory and clinical strategies for submissions, market authorization, and registrations worldwide.
Ann Niedzinski, MT(ASCP), CHS(ABHI) - Secretary
Evelyn Cadman - Treasurer
Principal, FDA Compliance Simplified
Carolyn Braithwaite-Nelson - Treasurer-in-Training
Senior Sterility Compatibility Engineer, Philips Image Guided Therapy Devices
Carolyn Braithwaite-Nelson is the Sr. Sterility Biocompatibility Engineer for Philips Image Guided Therapy Devices located in Colorado Springs, Colorado. Carolyn has over twenty years of experience working for global medical device manufacturer’s, providing technical, regulatory, and quality support for microbiology and toxicological issues. Her current responsibility include ongoing strategic and technical support for biological evaluation and technical support as needed for sterilization, manufacturing cleanrooms/controlled environments, particulate, bioburden and bacterial endotoxin testing programs. Carolyn is currently a member of ISO TC 198 WG08 and several ISO TC 194 Working Groups. She is also an active member of several AAMI ST sterilization and BE biocompatibility working committees.
John Mann - Program Chairman
Director, Evergreen Research
Mr. Mann has established himself as a leader in the overall integration and execution of regulatory affairs & quality system planning and execution into the medical device design, development, and manufacturing continuum. During his over 25 years in the medical device field, he has successfully implemented regulatory approvals for medical devices in both the US, EU and other global markets. He has successfully mitigated and remediated recall and market withdrawal situations for large and small companies, and he has designed and implemented Quality Management Systems (QMS) for all classes of devices, compliant to USA, EU and global market requirements.
Mary Armstrong - Member at Large
Regulatory Professional Retired
Mary Armstrong has been in the medical device arena for over 40 years. She got her start working in the Biomedical Electronics Department at Ohio State University Hospital. After receiving a Master’s degree in Biomedical Engineering from Case Western Reserve University, she worked for the FDA Denver District Office as a Field Biomedical Engineer. She then moved to industry, working in Quality and Regulatory Affairs for a small, dental implant manufacturer and a large, life-sustaining device manufacturer. She has been consulting since 2001 in the medical device and tissue areas
Darren Doherty - Member at Large
Director of Quality Assurance, Flagship Biosciences
Darren Doherty has B.S. in Chemical and Biochemical Engineering from the Colorado School of Mines and has over ten years of quality and regulatory experience in medical device, pharmaceutical, and biotech. Currently, Darren is the Director of Quality Assurance at Flagship Biosciences. Flagship Biosciences is CAP/CLIA laboratory located in Westminster Colorado and offers histology, pathology, and image analysis services to deliver the most accurate and informative tissue data available to clients. As head of the Quality Assurance department Darren leads the team that is responsible for all aspects of Flagship’s QMS and supports the regulatory and compliance components of Flagship’s business. Darren also serves on the Rocky Mountain Regulatory Affairs (RMRAS) steering committee.
Celso Duran - Social Technology Chairman
Product Associate, Regulatory Affairs, Medtronic, PLC.
Celso began working in the medical device industry in 2013. As a product associate in regulatory affairs, he is responsible for working with project teams throughout the device development process, obtaining 510(k) clearance from the FDA, preparing the MDD Technical File, and writing regulatory strategies. Celso received his Bachelor’s of Science in Bioengineering from Rice University and a Master’s of Science in Biomedical Engineering with a thesis in Tissue Engineering from Colorado State University.
Nan Matthews - Association Manager
President, The Matthews Group (TMG)
The Matthews Group has worked with RMRAS for over 15 years responsible for maintaining the membership database, sending out email announcements, acting a contact point for questions, as well as planning and executing their monthly meetings and annual seminars. Since 1998, TMG has specialized in technical meeting and conference planning for the medical device, biotechnology, dietary supplement and scientific research industries. Whether a local event with 50 in attendance or an international symposium hosting 200, Nan Matthews handles all meeting requirements from establishing the budget to site selection to website registration and credit card processing to day-of facilitation. Clients have included AdvaMed, AAMI, University of Colorado, Rocky Mountain Poison and Drug Center, ASME Colorado Section, and the Rocky Mountain Dietary Supplement Forum.
RMRAS is a nonprofit corporation classified by the IRS as a public charity under section 501(c)(3) of the Internal Revenue Code.