Amit Padhy

amit-padhy

Amit Padhy

Associate Technical Manager

Background

Mr. Amit is a Biomedical Engineer with a strong background in medical device technology. With over 8 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.

Background

2021 – Present

Associate Technical Manager, Elexes (Bangalore, India)

2020 – 2021

Associate Reviewer, Elexes (Bangalore, India)

2019 – 2020

Biomedical Engineer RA/QA, Elexes (Bangalore, India)

2011 – 2018

Service Engineer, MKCG Medical College & Hospital (India)

2017 – 2018

Biomedical Engineer, BPL Healthcare (Delhi, India)

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

Contact Info

Email: amit@elexes.com
Number: +91 7899544400