Edwin Bills
During his 35 year career in medical devices, Ed has held a number of quality and regulatory affairs positions. He is an ASQ Fellow and is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/Organizational Improvement. Ed is also Regulatory Affairs Certified through the Regulatory Affairs Professionals Society. Ed served as US […]
Eric Pettes
Eric Pettes is a QMS and Cybersecurity transformation consultant. Eric’s medical device experience spans 30 years and includes all facets supporting medical device and combination products for the world’s leading Pharma and Med Device companies. Eric’s cybersecurity experience spans 10 years and includes establishing Cybersecurity Management Systems for the automotive sector (ISO/SAE 214340), Secure Product Development Frameworks for the medical […]
John Nagle
John Nagle is an experienced QMS trainer and consultant with over 30 years of experience in medical device, medical consumables, pharmaceutical consumables, and parental drug injectables, as well over 20 years in the In Vitro Diagnostics industry. He has held positions in companies ranging from 10-20 person startups to multinational companies. John has worked for […]
Alyce Nelson
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 […]
Ken Campanale
Ken is a senior executive and educator with experience in global Regulatory Affairs, Clinical Research, Quality Systems, and R&D in the Medical Devices industry. His key accomplishments include implementing new product development processes and design controls within global regulatory requirements and ensuring timely product clearances with FDA and regulatory bodies worldwide. Ken has served as […]
Lori Kahler
Lori Kahler is a highly accomplished professional with over 30 years domestic and international experience in the management of operations, quality, regulatory, and compliance, with proficiency across a full range of business functions and systems, including strategic development and planning, budgeting, business analysis, finance, and information systems. Lori has successfully directed strategic programs in support […]
Natalya Koshnitsky
Natalya Koshnitsky has served as the Director of Quality Systems and Regulatory Affairs where she successfully designed and implemented a global quality management system and obtained an umbrella ISO 13485 certification for three facilities in the US and Central America. She is highly experienced in all areas of quality management system and compliance, including but […]
Steven R. Rakitin
Steven R. Rakitin has over 45 years’ experience as a software engineer including 35 years of experience in the medical device industry. He has worked with over 130 medical device manufacturers worldwide, from startups to Fortune 100 corporations. He has published papers on medical device software risk management as well as a book titled: Software […]
Angelo Scangas
Angelo has more than 35 years of experience in engineering, quality systems, operations and process improvement (Lean Six Sigma) in the Medical Device, Automotive, Aerospace, Consumer, Electronic, Healthcare, and Chemical Industries. His background includes product development, design/process engineering, supply chain management, supplier quality, quality system design and implementation (ISO 9001, ISO 14001, ISO 13485, IATF […]
