Alyce Nelson

Consultant, Quality/Regulatory Systems/Professional Development

Alyce Nelson holds a bachelor’s degree in Mechanical Engineering from the University of California, a post grad certification from MIT in Cardiovascular Anatomy & Pathophysiology for Scientists and Engineers, a diploma from the Krieger Institute of Canada in Clinical Research, an Exemplar certification as a Lead Auditor for Medical Devices, and a certification as a Professional Leadership Coach and Life Coach through the Institute of Professional Excellence in Coaching (IPEC), born out of Harvard and accredited by the International Coaching Federation.

Alyce has spent over 30 years in the medical device industry, 20 of which have been in the start-up arena, in Class II and Class III medical devices. Her most notable start-up experience was with ACS, which later became Guidant after the Eli Lily acquisition. She has worked in the product areas of spinal implants, bioresorbable implants, oxygenation, filtration, catheters, stents, guidewires, defibrillation, ablation, IVD, concussion, and sleep diagnostics.

Alyce began her career with an initial engineering emphasis on pilot development manufacturing, progressing to new product development, R&D, and later into process engineering, and project management. After covering this breadth of engineering, she changed things up by expanding into quality, regulatory, and clinical attaining the highest position of Vice President before beginning her own successful consulting, training, and coaching practice where she’s delivered in the areas of mergers and acquisitions, establishing quality systems, auditing, EU-MDR transitions, CAPA and Complaints, expert witness, clinical trials monitoring, recalls, risk management, department turn arounds, and difficult remediations.

Alyce served 2 consecutive terms on the Advisory Board for the CBI Summit on Product Recalls held jointly in Washington DC with the FDA and serves on the faculty of QSG (Quality Support Group). She holds professional affiliations with Medical Device Group-Boston (MDG), American Society of Quality (ASQ), Regulatory Affairs Professional Society (RAPS), and is also active with the International Coaching Federation (ICF), and National Speakers Association (NSA).

In her spare time, she enjoys many outdoor activities, hanging out with her beagle, entertaining, singing, Patriots football, and is an avid reader.

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