John E. Lincoln assists medical device/pharmaceutical companies with production and validation issues including gamma sterilization; QS, 510(k)s, export clearance, injection molding and training. He’s conducted webinars since they first started, workshops and in-company training, and written several chapters in books offered by RAPS and others on verification and validation subjects, to name a few.
He’s compiled many 510(k)s and some IDE’s. He assisted a software development team in the compiling of the software documentation necessary to obtain an IDE for a device that connects to the human brain and allows the thoughts of one paralyzed to move a cursor on a screen to communicate. Another project was for a US-based company, and two European affiliates, and their device that used software and ultrasound for precise positioning of a surgical probe to pinpoint areas of brain malfunction.
During John’s career both as a consultant and with Abbott Critical Care Systems as a Senior Manufacturing Engineer and Senior QA Engineer and QC Supervisor, and Surgical Technologies as a Director of QA/RA, he has introduced SPC / six sigma methodologies; facilitated recalls, and developed systems for tracking and reporting operations.
As a consultant for the last 26 years, he has established quality systems and procedures for start-ups, performed numerous software, hardware, and sterilization validations, performed FDA remediations addressing 483s and Warning Letters, and been part of an FDA / Industry Grass Roots program. He is experienced with EU MDR/CE marking (EN 46001) compliance, complaint, failure investigation, root cause analysis, and CAPA/trending systems of electro/mechanical, cardiovascular, ophthalmic and neurological products. He also designs and performs software verification/validation programs for ERP systems and 21 CFR Part 11.