Raje Devanathan
Certified QA/RA Leader | 22+ Yrs Life Sciences | QMS, MDSAP, FDA, EU MDR | eQMS & Digital Compliance Expert
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 executing global QMS strategies across North America, the EU, and APAC, Raje is adept at leading electronic QMS (eQMS) rollouts, conducting internal and external audits, and driving continuous improvement. Raje is recognized for building and mentoring high-performing teams, aligning digital compliance strategies with business objectives, ensuring data integrity, and enabling successful digital transformation. Their extensive experience includes hosting multiple successful regulatory authority inspections (FDA, HC, EMA) and hands-on proficiency with various compliance platforms.
HQ:
Canada
Languages:
English, German, Tamil, Hindi
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Predicate Research & Substantial Equivalence Strategy, 510(k) RTA Remediation / Refuse-to-Accept Fix, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
23
Num510k Submitted:
50
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd, wearable_digital, other
Technology Types:
samd, ai_ml, mobile_app, cloud_platform, ivd_test
Accepting New Clients:
No
Supports Estar:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
