(571) 447-5500

John Lincoln

EAS Independent Consultant

John Lincoln assists medical device/pharmaceutical companies with production and validation issues including gamma sterilization; QS, 510(k)s, export clearance, injection molding and training. During his career both as a consultant and with Abbott Critical Care Systems and Surgical Technologies, he has introduced SPC / six sigma methodologies; facilitated recalls, and developed systems for tracking and reporting operations. He is experienced with EU MDD/CE marking (EN 46001) compliance, complaint/FI/root cause/trending systems of electro/mechanical, ophthalmic and neurological products. He also designs software verification/validation programs for 21 CFR Part 11.

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