Parul Chansoria

Parul_Chansoria_Founder _and _CEO

Parul Chansoria

Founder and CEO

Background

Ms. Parul is a Biomedical Engineer by profession with more than 10 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.

Chronology

2014 – Present

Founder and CEO at Elexes (Dublin, CA, USA; Bangalore, India)
Acting Quality and Regulatory Director of medical device companies (Globally)

2014

Senior Regulatory Specialist at Intuitive Surgical (Sunnyvale, CA, USA)

2013 – 2014

Senior Regulatory Specialist at Outset Medical (Sunnyvale, CA, USA)

2012 – 2013

Regulatory Affairs at Stryker Corporation (San Jose, CA, USA)

2009 – Present

Regulatory Affairs Professionals Society Member (RAPS) (Palo Alto, CA, USA)
Regulatory Consultant and Trainer (several medical device and IVD companies)

2007 – 2009

Researcher at the Department of Cardiology, UIC (Chicago, Illinois)

Skills

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

Contact Info

Email: parul@elexes.com
Number: +1-408-475-809