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March 14, 2023

Quality Management System

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DHF Services

    Amit Padhy
    Associate Technical Manager

    Background
    Mr. Amit is a Biomedical Engineer with a strong background in medical device technology. With over 10 years of overall experience where 6 years were spent by Amit in core medical device troubleshooting and compliance, Amit is able to adopt a very pragmatic approach when helping Clients with testing and compliance issues. Amit is a dedicated professional with attention to details. He has helped successfully navigate many Clients through various stages of regulatory approvals.

    Skills:

    • Software as a Medical Device (SaMD)
    • Regulatory affairs
    • Clinical Evaluation Reports (CERs)
    • Risk management and testing per ISO 14971 and IEC 60601 standards
    • Active medical devices
    • IVDs

    Dr. Mark Harman
    Clinical Advisor

    Background
    An executive with 15+ years of global, medical and research experience. Demonstrated successes through NIH grant acquisition, board certification, launch campaigns, and executive leadership. Proven industry experience across multiple therapeutic areas (Oncology, Psychiatry, Neurology, etc): Medical Affairs (MA) operations – Medical Education & Writing – Clinical research (P1-4) – Regulatory Affairs – Strategy – leadership –organizational development. Medical Affairs management experience has continually been enhanced from developing new departments to assisting well-established ones for companies with annual revenues of $10M to multi-billion. A natural leader that leverages innate and trained communication skills to effectively coach staff, build talent, develop robust teams, minimize conflict, and drive projects to successful completion with a sense of purpose and attention to detail.

    Skills:

    • Clinical Research & Clinical trials
    • Pharmaceutical industry
    • Medical & Grant Writing
    • Regulatory Affairs
    • Medical Devices & Medical affairs
    vivek

    Vivek Goyal
    Co - Founder

    Background
    Mr. Vivek Goyal is an IIT Electrical Engineering and Stanford GSB alumni. He is highly passionate about creating successful businesses, helping companies optimally position themselves and their value proposition, and solving various complex technological problems through advanced software methodologies.

    Skills:

    • Product Management
    • Business Development
    • Software Development
    • Mobile Commerce

    Parul Chansoria
    Founder and CEO

    Background
    Ms. Parul is a Biomedical Engineer by profession with more than 15 years of medical device and IVD experience. Parul is a Certified Quality Auditor (CQA) by American Society for Quality (ASQ), RAC certified by RAPS, a trusted thought leader and a decision maker for regulatory strategy, product testing, design controls, risk management, supplier control, quality assurance, regulatory compliance, clinical evaluations, and post-market controls. With a Masters in Bioengineering from UIC, Chicago, she is passionate for medical device and IVD development and has served as the Regulatory and Quality Director for several medical device companies across the world.

    Skills:

    • European CE Marking
    • FDA Submissions 
    • Regulatory strategy
    • Clinical Evaluation Reports (CERs)
    • DHF, risk management, and testing
    • International regulatory requirements
    • ISO 13485, MDSAP, and FDA QSR compliance