Medical Device Consulting




Specializing In:


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Program Management

IEC 60601-1 3rd Edition Compliance

Compliant SOP Gap Analysis and Creation

   (Risk, Usability, Software, Clause 14)

Software Quality Assurance

Leading & Coordinating Multi-Business Projects

Michael Barsness

(774) 922-7618

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Medtronic President said: "Mike has a reputation for getting things done on-time and within budget."
  • Getting Your Product to Market

    24 Years Experience Managing Teams, Departments, Divisions, Outsourced Vendors


    Budgeting, Product Definition, Assembling and Leading Resources, Planning, Feasibility, Risk Management, Design, V&V, Submission, Stage Gates, Transfer to Mfg

  • Program Management

    Leading Cross-Functional Teams:


    • Globally dispersed (India, Canada, U.S.)

    • Embedded Systems with Class III SW

    • Pacing, Endoscopy, Drug Delivery, IV

    • Scientists, Engineers, Mfg, Verification

    • Budgeting, Planning, Communicating

  • Software Quality Assurance

    26 Years in Software Product Development


    • Created medical grade agile process

    • Led software safety classification analysis

    • 62304 compliance audit, SOP upgrades

    • Compiling evidence of software validation

    • Leading teams new to medical

  • Transfer to Manufacturing / Cost of Goods

    Leading Manufacturing Transfer:

    • Cost of Goods Reduction

    (Past Successes: -20%, -64%, -58%)

    • High Volume Embedded Disposables

    • Capital Equipment

    • Software, Embedded Systems

    • Test Fixture Design & Qualification

    • Production Automation Equipment Design

  • Outsourced Vendor Management

    Experience Leading Outsourced Firms


    • Hardware, Software, Mechanical Design

    • Human Factors Engineering

    • Manufacturing

    • Class II, III

    • India Engeering Firms

    • Training Firms, Test Houses (60601)

  • Due Diligence

    30 Years of Experience in Design & Mfg


    • How will the product change practice?

    • Has the technology really been proven?

    • Are they really ready for FDA? Testing?

    • What's the team's track record?

    • What's the status of transfer to mfg?

    • Is the product producible? Reliable?

  • IEC 60601-1 3rd Edition Compliance

    Steps to 3rd Edition Compliance


    Gap Analyze & Upgrade SOP'S and Evidence of:

       - Risk Management to 14971

       - Usability to 62366

       - Programmable Devices to Clause 14 / 62304

    Complete 3rd Edition Checklists, TRF's, Gap Fill



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