Due to comments such as the following, the majority of our assignments are the result of referrals:
Selected / listed in Marquis's (the original) WHO'S WHO (5th Ed.) in Science and Engineering
"Your [John E. Lincoln's] responses saved [the company] from a Warning Letter..." -- a western US
Resident Post official, U.S FDA
"I recently attended a two-day medical device seminar given by John. Topics of discussion were DHFs, Design Dossier and Technical Files. John did an excellent job discussing these topics. The group breakout sessions generated lively discussions and it was interesting to learn from the experiences of others attending the seminar." - Recent workshop attendee
"Your rewrites or compilation of our 510(k) device software documentation allowed us to meet the FDA's requests and proceed with their review for our client" -- a SE U.S. consulting company.
"Our IDE has been approved by the U.S. FDA for clinical trials." -- software documentation requirements structured by us for a system to translate human thought to cursor movement on a computer screen -- a UT and E coast research and start-up company
"We got our 510(k) (with software) cleared, no additional questions ... thank you so much for helping us pull that together." RG, principal, a U.S. medical device company
"_______ can be thankful it brought you on board for these projects..." -- a senior QA vendor auditor for a West Coast device company
"Your audit discovered an activity we didn't know was going on (the shpping of medical equipment software upgrades by IT department direct to customers, as "a favor")" -- a Southwestern medical products company
"Your attention to the continuing discussion to which ___ has committed is most appreciated and is at the heart of what we aim to cultivate and share within the Industry...It is through input from experts such as yourself, that this commitment may be satisfied and awareness and understanding continues to grow." -- Editor of an international regulatory journal
"Your initial advice has already saved us many thousands of dollars and months of delays in heading in the wrong direction in our planned approach, design and testing." -- CEO, start-up medical device company, UT
"You are the Greatest! I really appreciate your assistance." -- international conference producer
"Thank you so much for getting back to me so quickly. I am in your debt!" -- Editor of an international regulatory journal
"Thank you for your ... quick response ... You have made working under a tight deadline much less painful than it otherwise would have been." -- JF, a southeast US company
"Thank you again for all your help during that conference, and for assisting in making it a success..." -- international conference producer
"Your character is above reproach... you are multi-talented. Your organizational skills are
well honed...you excel at supervising and motivating others. You have performed every
task given you promptly and professionally...exceed what would normally been required.
Your advice in helping us define company goals has matched your keen ability to
recognize problems and determine solutions." -- RS, Exec. VP, UT
"John was responsible for filing and successful issuance for...510(k)'s. A very successful
and intensive FDA audit of our operations and facilities. His depth of knowledge and
understanding of the industry has helped all phases of our organization...manufacturing and quality
performance...has been
improved exponentially from his expertise...extremely competent and hard working...a
"machine" in the way he approaches his work. He has been the most productive and
competent person I have had the pleasure of working with. I highly recommend Mr.
Lincoln to your organization. You could not have a more professional or competent
person to assist you." -- TC, VP Finance, UT
"I just spoke with FDA's___...is completing his review of the ___510(k)...He expects to
complete the SE letter within the next two weeks...complemented [company] on the
510(k). My thanks to [subsidiary] and John Lincoln." -- RH, VP RA/Clinicals, CA
"___and___have recommended you for an award...for the significant contribution you
made...I'm very pleased to join them in acknowledging your achievement, which is "above
and beyond"...your extra efforts help make us a leader." -- DB, CEO, IL
"John has provided excellent liason with the various Engineering, Software, Design
Drafting and Support engineering departments...He is...dedicated...I recommend him
highly for the job performed." -- WW, Config'n Engineering Manager, UT
"Your performance...was characterized by outstanding ability, initiative, and
professional knowledge... The extra effort and meticulous attention to detail...
immeasureably decreased the problem areas related to our operations and has
earned you the respect and admiration of your peers and supervisors...The company
has lost an individual with a more than his share of professional competence.
Thank you." -- MB (and WL), Group Manager, CA
"...distinguished himself by exceptional achievement in performance of assigned duties
...agressive leadership and determination...outstanding performance of duty reflects
great credit upon himself..." -- JM, Site Manager, CA
"IVT (Institute of Validation Technology) 2017 Author of the Year"
Note: Supporting documentation is maintained on file at J. E. Lincoln and Associates LLC's office, and is available for review.
Medical Devices / Pharmaceuticals / Quality / Regulatory Affairs