Skip to content
Resources

Rohit Nambiar

Regulatory Affairs Manager, RhythmRx

Rohit Nambiar is Regulatory Affairs Manager at RhythmRx, working on FDA 510(k) and EU MDR submission strategy, Pre-Submission planning and ISO 13485 quality system implementation.

One article

Published by Rohit Nambiar.

Two-Thirds of 510(k)s Get a Deficiency Letter. The Deficiencies Are Almost Never About the Device.

Around two-thirds of 510(k)s receive a deficiency letter, and almost none of the deficiencies concern whether the device works.

Rohit Nambiar

Next step

Working on something in this area?

Tell us what you are building and where it is stuck.