J. E. Lincoln and Associates LLC

Medical Device Consulting



John E. Lincoln, consultant, assists companies in the design and implementation of complete 21 CFR 111, 210, 211, 820 and ISO 13485 quality management systems, fully CGMP-compliant, and which have passed FDA audits. He compiles 510(k) submissions, product Risk Management Files/Reports per ISO 14971, Design History Files, Technical Files /Design Dossiers. He assists companies in remediation/FDA responses, SOPs, audits, validations, including software. His work is described in peer-reviewed technical articles and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects. He has over 28 years of experience, primarily with medical devices working with start-ups to Fortune 100 companies. John serves on the Reader and Editorial Review Boards of MDDI Magazine, the Journal of cGMP Compliance, and writes an on-going medical device column for the Journal of Validation Technology. He is a graduate of UCLA.

Address :
P O Box 2786
City :
St. George
State/Zip, County/PostCode :
UT 84771-2786
Country :

Contact Name :
John E. Lincoln
Telephone :
Email :
Website :

Services :
Coaching, Health & safety, Management Consulting, New product development, Pharmaceuticals, Project management, Quality assurance, Risk management, Training & learning
US Coverage :
All US
UK Coverage :
All UK
Clients :
see website
Employees :
1 plus associates as needed