Bio

John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years of experience in U.S. FDA-regulated industries, 18 of which as a full-time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China, and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits, problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment including QMS and software validations, ISO 14971 product risk management files/reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, and Regulatory Affairs, to the level of Director and VP (R&D).