Dan (Dharmesh) Modi

Dan (Dharmesh) Modi Email and Phone Number

Compliance Consultant - Quality System and Regulatory Standards @ Karl Storz Imaging
Irvine, CA, US
Dan (Dharmesh) Modi's Location
Irvine, California, United States, United States
Dan (Dharmesh) Modi's Contact Details

Dan (Dharmesh) Modi personal email

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Dan (Dharmesh) Modi phone numbers

About Dan (Dharmesh) Modi

1. Over 30 years of Medical Device industry experience in Standards Certification / Design Quality and Regulatory.2. Excellent results working with Medical Device Start-ups as well as Fortune 500 companies.3. Expertise in key Electro-Medical safety standards - IEC 60601-1 (Electrical safety), IEC 60601-1-2 (EMC), and other Collateral and Particular standards. Certified EMC Engineer & Certified Safety Engineer (NARTE/Exemplar Global).4. Experience in DHF & Tech File auditing. Detailed knowledge of global quality system e.g. QSR, EN ISO 13485, JGMP, CMDCAS, etc. Certified Biomedical Quality Auditor (ASQ).5. Hands-on experience and knowledge for global medical device regulatory requirements for Electro-Surgical Devices – e.g. developing Global STeD, reviewing 510(k)s, etc. - Regulatory Affairs Professional Society (RAC) certification for US, EU and Canada.6. Detailed knowledge of Risk Management for medical devices (previous member of the AAMI working group for the ANSI/AAMI ISO 14971).7. Excellent communication and presentation skills – Taught various courses in the industry / symposiums / colleges.

Dan (Dharmesh) Modi's Current Company Details
Karl Storz Imaging

Karl Storz Imaging

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Compliance Consultant - Quality System and Regulatory Standards
Irvine, CA, US
Dan (Dharmesh) Modi Work Experience Details
  • Karl Storz Imaging
    Compliance Consultant - Quality System And Regulatory Standards
    Karl Storz Imaging
    Irvine, Ca, Us
    View
  • Karl Storz Imaging
    Compliance Consultant - Quality System & Regulatory Standards
    Karl Storz Imaging 2015 - Present
    El Segundo, California, Us
    View
  • University Of California At Irvine (Uci) - Extension
    Instructor - Regulatory Requirements (Medical Product Development Certificate Program)
    University Of California At Irvine (Uci) - Extension 2000 - Present
    Irvine, Ca, Us
    View
  • Alcon Laboratories, Inc.
    Director (R&D Surgical) - Global Ra Support / Product Certification
    Alcon Laboratories, Inc. 2012 - 2014
    Geneva, Switzerland, Ch
    View
  • Alcon Laboratories, Inc.
    Associate Director (R&D Surgical) - Design Quality / Regulatory Affairs
    Alcon Laboratories, Inc. 2004 - 2012
    Geneva, Switzerland, Ch
    View
  • Alcon Laboratories, Inc.
    Asst. Director (R&D Instrumentation) - Product Certification (Regulatory Standards Compliance)
    Alcon Laboratories, Inc. 1999 - 2004
    Geneva, Switzerland, Ch
    View
  • Alcon Laboratories, Inc.
    Product Certification Engineer (R&D Instrumentation) - Emc & Safety
    Alcon Laboratories, Inc. 1995 - 1999
    Geneva, Switzerland, Ch
    View
  • Compatible Electronics, Inc.
    Engineering Director - Standards Certification
    Compatible Electronics, Inc. 1986 - 1995
    Lake Forest, Ca, Us
    View

Dan (Dharmesh) Modi Skills

Medical Devices Regulatory Affairs Fda Iso 13485 R&d Product Development Design Control Biomedical Engineering Quality System Capa Validation Testing Cross Functional Team Leadership Biotechnology V&v Gmp Sop 21 Cfr Part 11 Iec 60601 Regulatory Requirements Training Change Control Regulatory Submissions Regulations 21 Cfr Research And Development Corrective And Preventive Action Lifesciences Medical Device Design Control Iec 60601 Series Electro Medical Standards Verification And Validation U.s. Food And Drug Administration 21 Cfr 820

Dan (Dharmesh) Modi Education Details

  • Uc Irvine
    Uc Irvine
    Medical Product Development
  • Pepperdine Graziadio Business School
    Pepperdine Graziadio Business School
    Mba
  • M.S University Of Baroda, India
    M.S University Of Baroda, India
    Major: Intrumentation

Frequently Asked Questions about Dan (Dharmesh) Modi

What company does Dan (Dharmesh) Modi work for?

Dan (Dharmesh) Modi works for Karl Storz Imaging

What is Dan (Dharmesh) Modi's role at the current company?

Dan (Dharmesh) Modi's current role is Compliance Consultant - Quality System and Regulatory Standards.

What is Dan (Dharmesh) Modi's email address?

Dan (Dharmesh) Modi's email address is dm****@****uci.edu

What is Dan (Dharmesh) Modi's direct phone number?

Dan (Dharmesh) Modi's direct phone number is (800) 757*****

What schools did Dan (Dharmesh) Modi attend?

Dan (Dharmesh) Modi attended Uc Irvine, Pepperdine Graziadio Business School, M.s University Of Baroda, India.

What are some of Dan (Dharmesh) Modi's interests?

Dan (Dharmesh) Modi has interest in Standards Certification Training, Regulatory Research.

What skills is Dan (Dharmesh) Modi known for?

Dan (Dharmesh) Modi has skills like Medical Devices, Regulatory Affairs, Fda, Iso 13485, R&d, Product Development, Design Control, Biomedical Engineering, Quality System, Capa, Validation, Testing.

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