John E. Lincoln, principal consultant, J. E. Lincoln and Associates LLC, assists companies in designing and implementing complete 21 CFR 111, 210, 211, 820 and ISO 13485 quality management systems that are fully CGMP-compliant and have passed FDA inspections and Notified-Body audits. He compiles 510(k) and IDE submissions, for new and changed devices, product risk management files and reports per ISO 14971, ICH Q9, design history files, and technical documentation files. He assists companies in remediation and FDA responses, SOP writing, audits and validations, including software. John has more than 42 years of industry experience, with 28 years as an independent consultant. He also has managed pilot production, regulatory affairs, new product development and design control and documentation projects.