CHARMAINE DWYER (SUTTON)
FOUNDER & PRINCIPAL CONSULTANT
Charmaine Dwyer (formerly Sutton) is principal consultant and founder of The Tamarack Group – MPLS, LLC, which was founded in 1991. The Tamarack Group is an association of consultants assisting developers and manufacturers of medical devices, diagnostics, pharmaceuticals, biologics and combination products to gain market access and comply with US, EU and worldwide regulatory requirements. Charmaine is also an adjunct professor in the St. Thomas University (St. Paul, MN) Master of Regulatory Science program.
Charmaine previously served as Sr. Vice President of Regulatory & Quality Assurance and Sr. Vice President of Operations at Vascular Solutions (Maple Grove, MN, now Teleflex) and served on the VSI Board of Directors. Charmaine is an expert in US and European regulations for all classes of medical devices and device combination products. She has proven expertise overseeing product and process development, ISO 13485 and US FDA QSR quality assurance and quality systems, product and process risk management, regulatory market authorizations, supply chain management and manufacturing operations, and post-market quality and regulatory support. Prior to The Tamarack Group, Charmaine held director- and VP-level engineering, regulatory, quality and clinical positions in start-up companies and was a research scientist in the laser fusion program at Lawrence Livermore National Laboratory. Charmaine has also served as adjunct professor for the regulatory affairs and services graduate program at St. Cloud State University. She has a degree in applied physics from UC Davis.
CAROL DeSAIN
ALLIED DRUG/BIOLOGIC CONSULTANT
Carol DeSain has been President of The Tamarack Group - NorthShore for more than 30 years providing compliance advice for the development and commercial production of pharmaceutical, bio-pharmaceutical, diagnostic, and combination products.
Carol is a biologist by education, training and experience. She has worked in the medical product industry with small, start-up companies, global corporations, and contract manufacturers in the US, Europe and Japan, working primarily with sterile products. She is known for her broad knowledge of the industry, a practical, hands-on approach to compliance, interactive and informative training sessions, and for the ten books she has co-authored with Charmaine Sutton on documentation, risk management, validation and product development. Books include Documentation Basics, Risk Management Basics and Documentation Practices.
DANIKA GREEN
SENIOR CONSULTANT
Danika Green is a senior consultant with The Tamarack Group. Danika has worked in the medical device industry for over 10 years, gaining skills and experience in the areas of clinical research, data management and database building, regulatory affairs, quality systems, and technical writing across a variety of product types. She attended undergraduate and graduate school at the University of Minnesota and earned bachelor’s degrees in global studies, Spanish, and biology, as well as a master’s degree in public health with an emphasis in epidemiology.
NOELLE SUTTON
SENIOR CONSULTANT
Noelle Sutton is a senior consultant with The Tamarack Group. Noelle has over 10 years of experience in regulatory and quality aspects of the medical device industry. She has worked both as a consultant and employee for medical device companies. Noelle’s experience includes quality system development, quality system management, regulatory submission preparation and post-market regulatory and quality support. Noelle has a degree in kinesiology from the University of Minnesota and a master’s degree in regulatory affairs from St. Cloud State University.
LAUREN BARNES
CONSULTANT IN REGULATORY AND QUALITY IN THE MEDICAL DEVICE INDUSTRY
Lauren Barnes joined The Tamarack Group in 2018 as a consultant in regulatory and quality aspects of the medical device industry. Lauren has a degree in communications and foreign studies from the University of Minnesota and a degree in nursing from Ridgewater College. Lauren has over 10 years of experience working as a Registered Nurse in the home care, hospice, skilled nursing, and long-term care settings. During this time, she held Licensed Practical Nurse, Registered Nurse, RN Case Manager, and Director of Nursing positions.
ASHLEY GRODE
CONSULTANT
Ashley Grode is a consultant with The Tamarack Group. Ashley has over two years of experience in quality and regulatory aspects of the medical device industry. She also has over two years of manufacturing and quality experience in the tissue banking industry. Ashley’s experience includes quality system development, quality system management, and she is a certified quality auditor with focus on ISO 13485 compliance. Ashley has a degree in criminal justice from Arizona State University with a minor in chemistry.