John Nagle – Consultant, Quality and Regulatory Systems

John Nagle is an experienced QMS trainer and consultant with over 30 years of experience in medical device, medical consumables, pharmaceutical consumables, and parental drug injectables, as well over 20 years in the In Vitro Diagnostics industry. He has held positions in companies ranging from 10-20 person startups to multinational companies. John has worked for companies including Nova Biomedical, Foundation Medicine, IQuum, GE Healthcare, Genzyme, Roche, and Medispectra Inc.. John has held several Head of Quality positions as part of his consultancy work for multiple VC start-up companies.

John’s experience encompasses capital equipment, software, and consumables/disposable products. He specializes in helping small companies create/upgrade their quality systems, become FDA/ISO audit ready and Establishment Registration ready. John has significant experience managing FDA Inspections (including BIMO), and in writing and responding to FDA 483 Inspection Observations, PMA Deficiency letters, and Product Recall communication responses. John has successfully managed ISO 13485 certification projects for both US and EU companies.

John attended the University of Lowell (Mechanical Engineering) and studied Information Services management at Northeastern University and Human Relations through Dale Carnegie Training. He is a member of ASQ, PDA Parenteral Drug Association, Regulatory Affairs Professional Society, Mass Medic, and AdvaMed.

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