Serving the medical devices / pharmaceuticals / neutraceuticals industries for over 37 years ... making good things happen:

Why contract with John E. Lincoln, principal of J. E. Lincoln and Associates LLC:

You get John E. Lincoln, not a less-experienced associate. Our "associates" are independent experts in their field, who are only brought in on a project if specialiazed expertise is needed and the client requests it.

We saved two Utah companies from receiving Warning Letters, by:

o immediate initial response;

o living Action Plans;

o proof of corrective action; and

o frequent (monthly) communication with the Agency.

One of the few regulatory consultants who have also designed, piloted, set up production facilities, validated, and brought to market medical devices. John has worked in R&D, Engineering, Manufacturing, Quality and Regulatory, providing a unique insight for the client.

Developed the software verification and validation plan and guided the software documentation team for a product to translate human brain signals from a brain chip implant into computer output for US clinical trials.

Wrote 8 page Design and Development Control SOP and Milestone / Task List, for a division of a multinational pharma / device company, to bring new products to market, 12 years before Design Control.

Set-up/staffed / trained a recall/tracking/reporting operation for a subsidiary of a major medical device company.

Wrote 164 risk management files to ISO 14971 for one client, and over 40 to date. Developed new SOPs and file templates for future file development in-house.

Drafted / administered software V&V protocols for 550T injection molding press, vision system, QMS (Quality Management Systems), ERP system applicable to CGMP issues, and new device 510(k)'s. Guided company personnel in running the protocols.

Helped solve EU MDR / CE / ISO 9001 / ISO 13485) compliance problems; wrote Declaration of Conformities, Technical Files and Design Dossiers (now Technical Documentation) for several clients.

Revised complaint/FI (failure investigation)/trending systems many clients, from start-up to $13 B internationals.

Wrote numerous electro/mechanical, ophthalmic, neurological (coordinated activities in Fr., Ger., US), drug delivery, etc., 510 (k)s.

Structured companies' validation of EO sterilization of medical devices, including chamber control software V&V.

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