Medical Consulting
MC

Medical Consulting

Linkedin Profile
President and Principal Consultant at Medical Innovation Technology Operations Consulting LLC | Warsaw, Indiana, United States
View Medical Consulting's Email & Phone Number

About Medical Consulting

  • As the President and Principal Consultant at Medical Innovation Technology Operations Consulting LLC, I leverage my extensive background in the medical device regulatory and quality system arena to provide unparalleled support to clients navigating the complexities of FDA regulations. With a Master of Science in...
    As the President and Principal Consultant at Medical Innovation Technology Operations Consulting LLC, I leverage my extensive background in the medical device regulatory and quality system arena to provide unparalleled support to clients navigating the complexities of FDA regulations. With a Master of Science in Bioengineering and firsthand experience as a reviewer at the FDA, I possess a unique perspective on the intricacies of regulatory submissions, including 510(k), PMA, and IDE submissions. My tenure in both the Office of Compliance and the Office of Device Evaluation has equipped me with a deep understanding of Quality System Regulations (QSR) and Good Manufacturing Practices (GMP), allowing me to guide clients through the entire product lifecycle—from concept to market entry. Currently, I specialize in FDA regulatory and quality system reviews, submission writing, and strategic analysis, focusing on innovative projects in the medical device sector, particularly in tissue engineering and cardiovascular devices. My role involves not only assisting with new product development initiatives but also leading remediation projects to address compliance gaps. I pride myself on fostering strong relationships with regulatory agencies, ensuring that my clients are well-prepared for interactions that can significantly impact their product approval timelines. Key projects I have undertaken include comprehensive quality system audits, corrective and preventive action (CAPA) implementation, and tailored regulatory strategies that align with clients' unique business goals. My commitment to excellence and my ability to translate complex regulatory requirements into actionable insights empower my clients to achieve their objectives efficiently and effectively, ultimately enhancing patient safety and advancing medical innovation.
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  • Medical Consulting Work

    • President and Principal Consultant at Medical Innovation Technology Operations Consulting LLC in July 2016 to Present
    • Regulatory Affairs Specialist / Quality Engineer at Medical Device Company in August 2012 to November 2015
    • Bioengineer at FDA in September 2010 to August 2012
  • Medical Consulting Skills

    • Medical DevicesU.S. Food and Drug Administration (FDA)Regulatory Affairs
      Regulatory SubmissionsFDA GMPQuality SystemCorrective and Preventive Action (CAPA)Tissue EngineeringCardiovascular Devices

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  • About Medical Consulting's Current Company

  • Frequently Asked Questions about Medical Consulting

    • What is Medical Consulting email address?
      Email Medical Consulting at m***g@fda.gov. This email is the most updated Medical Consulting email found in 2024.
    • How to contact Medical Consulting?
      To contact Medical Consulting send an email to m***g@fda.gov.
    • What company does Medical Consulting work for?
      Medical Consulting works for Medical Innovation Technology Operations Consulting LLC
    • What is Medical Consulting's role at Medical Innovation Technology Operations Consulting LLC?
      Medical Consulting is President and Principal Consultant
    • What is Medical Consulting's Phone Number?
      Medical Consulting's phone (317) ***-*271
    • What industry does Medical Consulting work in?
      Medical Consulting works in the Government Administration industry.

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