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Medical Device Consulting - Mahmood Mirza


Specializing in clinically-oriented design, Mahmood applies his medical knowledge, engineering skills, and entrepreneurial spirit to creating simple innovative designs in the medical device arena.
  • Innovative Design

    Brainstorm ideas that that are incrementally or fundamentally innovative that solve a specific clinical goal with simple and easy to manufacture engineering principles.

  • Engineering

    Design and develop the idea following well-established iterative principles. Start with customer needs to develop design inputs, and use FMEA or other risk analysis tools to iterate the design.

  • Verification and Validation

    Create testing protocols for bench testing, animal testing, and clinical testing to verify the design and validate its clinical use.

  • Regulatory / IP Submisisons

    Create and respond to FDA 510(k), EU, and Health Canada submissions, as well as the rest of the world. Create value by filing design and process patents.

  • Marketing and Sales

    Create a well-formed marketing strategy using word-of-mouth, clinical studies, conferences, publications, and medical leaders. A great idea doesn't sell itself - focus the sales strategy for greater success.

Consulting Services

Consulting Services

Clinical / Technical Services:

  • Research and Development (R&D)
  • Intellectual property (IP), Patents
  • Clinical Study Design, Data Analysis
  • Preclinical Study Design, Data Analysis
  • In Vitro Models
  • In Vivo Models
  • Data and Statistics, Bayesian and Frequentist
  • Medical Writing, White Papers, Publications


  • IDE, 510(k), PMA, ANDA, NDA
  • Liaison with FDA
    Learning Sessions

    Learning Sessions

    Mahmood has over 10+ years in medical device design and development, along with a medical degree.  Mahmood can deliver presentations and tutorials for your employees, customers, engineers, sales staff, or management on medical topics relevant to your company and aimed at the appropriate audience.

    • Anatomy, Physiology, and Pathology of Desired Application Area
    • Medical Device Design for Young Engineers
    • Basic Medical Sciences for Engineers
      Medical Device R&D Resources

      Medical Device R&D Resources

      Mahmood can help create quality documents, white papers, flowcharts, presentations, and prepare marketing analysis for your clinical need.  Check out these publicly available resources:

        Contact Us

        Contact me for any questions and inquiries. I will respond as soon as possible.

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