The Cogmedix Team

The following team consists of Cogmedix current leadership as well as consultants who assisted in establishing a strong and compliant manufacturing and fulfillment services company created to meet your medical device contract manufacturing needs with quality, compassion and compliance.

Cogmedix Biographies

  • Scott Cook
    Director of Compliance & Regulatory
    Cogmedix Inc.

    Prior to joining Cogmedix, Mr. Cook was the Associate Director, Regulatory Affairs & Compliance at Charles River, Inc.

    Mr. Cook has seventeen years of experience in FDA regulated businesses including roles in clinical logistics, quality assurance auditing, and more than ten years in senior level regulatory compliance roles. He is on the board of directors of the Society for Quality Assurance, was the past president of the New England Chapter, and has been a member since 2000. Prior to Charles River Mr. Cook worked for Primedica, Biogen and Astra, USA in quality related roles.

    Mr. Cook has a BS degree from University of Lowell and a Biotechnology Technician Certificate from Quinsigamond Community College.

  • Matt Giza
    General Manager
    Cogmedix Inc.

    Prior to his joining Cogmedix as General Manager, Mr. Giza was Director of Sales and Marketing for Zygo Corporation’s Optical Systems Division. As a member of the senior management team, he helped evolve and lead the overall business strategy for the division and was responsible for business development and diversification strategies, with a significant focus in the Life Sciences market. Prior to that Mr. Giza was Director of Worldwide Sales and Service for GSI Group’s optical scanning product line where he was responsible for worldwide sales, service, technical support, and collaborating on product marketing strategies focused on gaining market share.

    Mr. Giza earned a BS in Mechanical Engineering from Worcester Polytechnic Institute and an MBA from Clark University. He has a proven track record of growing sales and a solid background in FDA-compliant manufacturing, fostering long-term trustful business relationships.

  • Bobby Hazelton
    Counsel
    Cogmedix Inc.

    Bobby Hazelton serves as Cogmedix, Inc.'s internal counsel assisting with transactional matters and regulatory affairs. Mr. Hazelton is a member of various professional organizations including the Worcester County Bar Association and the American Intellectual Property Law Association. He also serves on the Human Rights Committee of the Seven Hills Foundation. He has served as a member of the Adjunct Law Faculty with Suffolk University Law School and Anna Maria College. At Suffolk, Mr. Hazelton has coached mock trial teams that have won seven consecutive New England regional championships. Mr. Hazelton was named a Massachusetts Rising Star in 2007 and recognized as a "40 Under 40" winner by Worcester Business Journal. He earned his J.D., cum laude, in 2002 from Suffolk University Law School and is a graduate of Auburn University, where he earned his B.S. in Applied Mathematics with a concentration in Physics in 1992.

  • Josh Paquette
    Project Manager
    Cogmedix, Inc.

    Prior to joining Cogmedix, Mr. Paquette served as a Manufacturing Engineer for Columbia Tech with a significant focus on medical subassemblies. Mr. Paquette was responsible for initiating and executing ECO’s, providing electromechanical support to the production team, and performing root cause analysis in support of the CAPA process. Mr. Paquette joined Cogmedix in May 2008, shortly after its founding, as Operations Manager and was promoted to Project Manager in 2010.

    Mr. Paquette earned a BS in Electrical and Computer Engineering from Worcester Polytechnic Institute.

  • Michael D. Ryan
    Consultant
    Accelerate Inc.

    Accelerate Inc. provides operations and technology expertise, strategy and solutions across the entire product lifecycle including product development, process improvements and world class operational execution enabling our customers to grow their businesses profitably.

    Prior to forming Accelerate Inc., Mr. Ryan served as Vice President of Instrument Operations and Global Logistics at Affymetrix. Leveraging Mr. Ryan’s operational leadership, Affymetrix launched a wide variety of Instrumentation products including the GeneChip® Scanner 3000 series (both RUO and IVD versions) and other capital equipment platforms. Additionally, during his tenure with Affymetrix, Mr. Ryan led the Instrumentation Operations team through successful achievement of ISO13485:2003 recognition as well as successful implementation of the Bedford Facility as the only FDA-registered site within the company. Further, Mr. Ryan led the interdisciplinary Global Logistics and Global Order Fulfillment teams.

    Mr. Ryan also served as Director of Manufacturing at Genetic MicroSystems, and in a variety of other operational and consulting roles, with increasing levels of leadership and responsibility, including successful positions at Coopers & Lybrand Consulting, Bose Corporation and General Electric. Prior to initiating his civilian career, Mr. Ryan served as an officer in the U.S. Navy. Mr. Ryan received a BS in Industrial and Management Systems Engineering from The Pennsylvania State University and his MBA from Bentley College.

  • Laurie A. Smith
    Consultant
    Accelerate Inc

    Prior to forming Accelerate Inc., Ms. Smith was Senior Manager of Instrument Operations at Affymetrix, Inc. Ms. Smith provided operational program management leadership for instrument manufacturing, planning, production control, order fulfillment, and facilities. Some of Ms. Smith’s accomplishments include ISO 13485:2003 certification, manufacture of the first FDA regulated instrument platform for microarray based diagnostics, implementation of lean manufacturing and 5S techniques, formation of a returns process and the instrument repair depot, and management of a successful global order fulfillment team. While at Affymetrix, Ms. Smith also served as manufacturing project manager for infrastructure projects such as manufacturing capacity expansion, global order fulfillment design, and European Distribution Center transition. Additionally, Ms. Smith participated in the implementation of a world class new product development process from product concept through to obsolescence.

    Before Affymetrix, Ms. Smith was a Manufacturing Engineer at Presstek, and was responsible for consumable supplier management and yield improvement program development. Ms. Smith also gained experience in R & D while at Iris Graphics where she formulated and scaled-up laboratory meyer rod coatings for commercial high resolution ink jet printers and consumables. Ms. Smith received a BS in Chemical Engineering from UMASS Lowell and a MBA in Management of Operations and Technology from Bentley College.

  • Jack Ward
    Consultant
    Ward Sciences and Consulting, LLC

    Ward Sciences and Consulting, LLC provides consulting services for companies requiring professional guidance on FDA and ISO medical device standards and regulations. Services include audits, Quality System document development/review, training, regulatory submissions and engineering analysis.

    Jack Ward has worked for over 25 years for entrepreneurial and Fortune 500 medical device companies. He has worked extensively in product development, managing large engineering teams distributed in the U.S. and Europe. Jack also has extensive medical device Quality Assurance and Regulatory experience, with past worldwide management responsibilities. He has been responsible for developing and implementing FDA and ISO compliant Quality Systems and has successfully hosted multiple FDA inspections and ISO audits. Jack has taught engineering courses at the university level and conducted numerous industry level Quality and Regulatory courses.

    Mr. Ward earned an MS in Computer Science from Boston University, is a member of the American Society for Quality (ASQ) with active certifications as a Certified Quality Manager (CQM) and a Certified Software Quality Engineer (CSQE). He holds an ISO 13485:2003 Internal Auditor Certification (BSI) and is an active faculty member of the Association for the Advancement of Medical Instrumentation (AAMI), qualified for teaching industry courses in FDA 21 CFR Quality System Regulation and FDA 21 CFR Design Control.

  • John Malloy
    Consultant
    Malloy & Associates

    Mr. Malloy is President and founder of Malloy & Associates. The company provides consulting, training, planning and auditing services to the medical device and pharmaceutical industries in the areas of FDA regulatory compliance and ISO quality systems.

    Mr. Malloy has over thirty years of experience within the medical industry, having served as an Investigator for the U.S. Food and Drug Administration (FDA), and having held industry management positions in regulatory, quality, marketing and operations. He has worked with the requirements of the Federal Food, Drug and Cosmetic Act (FFDCA) from both the FDA and private industry perspectives, providing consulting, auditing, training and strategic planning services to domestic and international companies ranging in size from start-ups to Fortune 100 companies. Mr. Malloy strives to assist companies in the establishment of a quality system that is an asset to the organization and meets regulatory requirements as a byproduct.

  • Jeremiah Beckwith
    Consultant
    JBeckwith, LLC

    Mr. Beckwith is President and founder of JBeckwith, LLC, a service-oriented regulatory and compliance affairs consultancy with expertise in Federal Regulatory Codes, Good Manufacturing procedures, and Developing and Maintaining FDA contacts.

    Prior to forming JBeckwith, LLC, Mr. Beckwith was the Vice President Regulatory /Government Affairs - Devices, Imaging and Pharmaceuticals at TYCO HEALTHCARE where he served as liaison to the FDA regarding regulatory and compliance issues, advised senior management on device labeling practices, successfully lifted an in-place Consent Decree, and successfully managed off-shore FDA audits of the firm’s manufacturing facilities.

    Mr. Beckwith has also served as Director Investigations Branch – Food, Drugs, Devices and Bioresearch at the U.S. Food & Drug Administration. Among his many accomplishments while at the FDA, MR. Beckwith successfully developed a precedent setting case that permitted FDA access to on-site records generated by weights and measuring certification laboratories for regulated food, medical device and pharmaceutical manufacturing facilities. He also established an electronic system for monitoring damage to regulated facilities/products in the aftermath of hurricanes in Puerto Rico and the U.S. Virgin Islands. He has served as FDA representative to FEMA, The Red Cross, Department of Defense, Department of Agriculture and the Health Departments of Puerto Rico and the U.S. Virgin Islands in emergency situations and also served as liaison to the DEA in establishing joint sample storage and analysis agreement for confiscated contraband. Mr. Beckwith also served as Supervisory Investigator – Drug and Bioresearch Monitoring Programs where he supervised an FDA team responsible for monitoring compliance with regulations covering pharmaceutical manufacture, audits of clinical investigators, institutional review boards and clinical laboratories and served as a member of the First Line Supervisors Advisory Committee, a recommending committee for mid-level and senior Regulatory Field Staff.

    Mr. Beckwith earned his degree in Environmental Biology from the University of District of Columbia, Washington, D.C., as well as completing the Advanced Drug Course: Bioavailability and Bio-equivalence (FDA developed) at the University of Utah, and the Basic Drug Course (FDA developed) at Rutgers University. He is a member of the Regulatory Affairs Professional Society, the Food and Drug Alumni Association and the Food and Drug Law Institute.

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