IMDS Consulting

FDA Regulatory Consultant

IMDS Consulting is a dedicated solo consultant with 10 years of experience specializing in FDA 510(k) regulatory consulting, with deep expertise in SaMD, Imaging, and Digital Health devices. This boutique consultancy focuses on 510(k), De Novo, and PMA submissions, offering expert guidance to medical device companies navigating FDA regulatory pathways and achieving successful clearances and approv...

Experience: 10+ years

Submissions: 10 510(k)

Professional Overview

IMDS Consulting is a dedicated solo consultant with 10 years of experience specializing in FDA 510(k) regulatory consulting, with deep expertise in SaMD, Imaging, and Digital Health devices. This boutique consultancy focuses on 510(k), De Novo, and PMA submissions, offering expert guidance to medica...

Core Specializations

Best suited for

• • MedTech companies seeking expert regulatory guidance

Experience signals

• Background: 10+ years of regulatory experience.

Cruxi view

IMDS Consulting offers a uniquely valuable service, leveraging 10 years of dedicated experience as a solo consultant specializing in FDA regulatory pathways. Their deep expertise is specifically tailored for innovative Class II medical devices, with a pronounced focus on Software as a Medical Device (SaMD), Imaging, and Digital Health technologies. This boutique consultancy provides comprehensive support across critical submission types, including 510(k), De Novo, and PMA, ensuring clients receive highly focused and personalized guidance to achieve successful FDA clearances and approvals. Their specialized knowledge in these high-growth technology areas, combined with a hands-on approach, sets them apart.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.