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
