RD

Raje Devanathan

Director, Quality Assurance and Regulatory Affairs

A highly accomplished and certified Quality Assurance, Regulatory Affairs, and Clinical professional with over 22 years of dedicated experience in the life sciences industry. Raje excels in implementing, standardizing, and certifying robust Medical Device Quality Management Systems (QMS), including expertise in ISO 13485, MDSAP, and FDA QSR compliance. With a proven track record of developing and ...

Experience: 23+ years

Submissions: 50 510(k), 10 De Novo, 5 PMA

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaPost Market

Device Specialties

IvdWearable DigitalOther

Regions Served

Raje Devanathan provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Canada (Health Canada)Asia-Pacific

Credentials & Recognition

Certifications

Global Regulatory Affairs
Humber College
2013
Medical Device Risk Management
2021
Medical Device Clinical Research
2021
Applied ISO 14971
2021
Medical Software & Clinical Trials
Yale University / Johns Hopkins University
2021
Clinical Research
Global Health Training Centre
2024
ICH Good clinical Practice E6 (R2)
Global Health Training Center
2024

Professional Experience

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

A highly accomplished and certified Quality Assurance, Regulatory Affairs, and Clinical professional with over 22 years of dedicated experience in the life sciences industry. Raje excels in implementing, standardizing, and certifying robust Medical Device Quality Management Systems (QMS), including ...

Core Specializations

Regulatory Pathways

510kDe NovoPmaPost Market

Device Specialties

IvdWearable DigitalOther

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Regions: US, EU, CA, APAC
  • Background: 23+ years of regulatory experience.

Cruxi view

With an impressive 23 years of experience, Raje Devanathan is a highly accomplished FDA regulatory consultant analyst uniquely valuable to medtech companies. Their deep expertise spans the entire lifecycle of medical device regulation, from robust Quality Management System (QMS) implementation (ISO 13485, MDSAP, FDA QSR) to successful global QMS strategies across North America, EU, and APAC. Raje's proven track record includes hosting multiple successful regulatory authority inspections (FDA, HC, EMA) and adeptness in complex submission pathways like 510(k), De Novo, and PMA, particularly for Class II and Class III devices including IVD and SaMD. Their proficiency in eQMS and digital compliance, coupled with a strong foundation in scientific principles from their MSc in Molecular Biology & Biochemistry, positions them as an indispensable partner for companies navigating stringent regulatory environments and driving digital transformation.

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

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