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.
About
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.
Additional information
### **Additional information**
- **Type:** firm
- **Years of experience:** 23
- **510(k)s submitted (self-reported):** 50
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC
- **Client types:** startup, sme, large_medtech
- **Location:** Canada
- **Availability:** available_now
- **Certifications:** Global Regulatory Affairs, Medical Device Risk Management, Medical Device Clinical Research, Applied ISO 14971, Medical Software & Clinical Trials, Clinical Research, ICH Good clinical Practice E6 (R2)
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Raje Devanathan offers a potent combination of deep scientific understanding, extensive hands-on regulatory experience across major global markets, and a forward-thinking approach to digital compliance and eQMS. Their proven success in managing high-stakes regulatory inspections and diverse submission types, coupled with their ability to build and mentor teams, distinguishes them as a comprehensive and strategic regulatory partner for medtech innovation.
- **Ideal projects:** This consultant is ideally suited for medtech companies, from startups to large enterprises, seeking to navigate complex regulatory landscapes for Class II and Class III devices. They excel in projects involving 510(k), De Novo, and PMA submissions, especially for innovative device types such as In Vitro Diagnostics (IVD), Software as a Medical Device (SaMD), and AI/ML-driven technologies. Engage Raje for establishing or optimizing QMS, managing international market access (US, EU, CA, APAC), leading eQMS rollouts, preparing for and hosting regulatory inspections, or when embarking on the crucial first submission for a novel device. Their extensive experience makes them a strong candidate for companies needing robust regulatory strategy and execution to achieve market readiness.
- **Confidence score:** 95/100
- **Last analyzed:** Fri Dec 19 2025 23:50:34 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, qms, international, de_novo
- **Device classes:** class-ii, class-iii
- **Specialties:** ivd, software-samd, other, quality system implementation, quality management systems
- **Device panels:** ivd, wearable_digital, other
- **Regulatory pathways:** 510k, de_novo, pma, post_market
- **Type:** firm
- **Years of experience:** 23
- **510(k)s submitted (self-reported):** 50
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC
- **Client types:** startup, sme, large_medtech
- **Location:** Canada
- **Availability:** available_now
- **Certifications:** Global Regulatory Affairs, Medical Device Risk Management, Medical Device Clinical Research, Applied ISO 14971, Medical Software & Clinical Trials, Clinical Research, ICH Good clinical Practice E6 (R2)
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Raje Devanathan offers a potent combination of deep scientific understanding, extensive hands-on regulatory experience across major global markets, and a forward-thinking approach to digital compliance and eQMS. Their proven success in managing high-stakes regulatory inspections and diverse submission types, coupled with their ability to build and mentor teams, distinguishes them as a comprehensive and strategic regulatory partner for medtech innovation.
- **Ideal projects:** This consultant is ideally suited for medtech companies, from startups to large enterprises, seeking to navigate complex regulatory landscapes for Class II and Class III devices. They excel in projects involving 510(k), De Novo, and PMA submissions, especially for innovative device types such as In Vitro Diagnostics (IVD), Software as a Medical Device (SaMD), and AI/ML-driven technologies. Engage Raje for establishing or optimizing QMS, managing international market access (US, EU, CA, APAC), leading eQMS rollouts, preparing for and hosting regulatory inspections, or when embarking on the crucial first submission for a novel device. Their extensive experience makes them a strong candidate for companies needing robust regulatory strategy and execution to achieve market readiness.
- **Confidence score:** 95/100
- **Last analyzed:** Fri Dec 19 2025 23:50:34 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, qms, international, de_novo
- **Device classes:** class-ii, class-iii
- **Specialties:** ivd, software-samd, other, quality system implementation, quality management systems
- **Device panels:** ivd, wearable_digital, other
- **Regulatory pathways:** 510k, de_novo, pma, post_market
Key Highlights
- 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
- Raje Devanathan offers a potent combination of deep scientific understanding, extensive hands-on regulatory experience across major global markets, and a forward-thinking approach to digital compliance and eQMS. Their proven success in managing high-stakes regulatory inspections and diverse submission types, coupled with their ability to build and mentor teams, distinguishes them as a comprehensive and strategic regulatory partner for medtech innovation.
Certifications & Trust Signals
- 23 years experience
- 50 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- This consultant is ideally suited for medtech companies, from startups to large enterprises, seeking to navigate complex regulatory landscapes for Class II and Class III devices. They excel in projects involving 510(k), De Novo, and PMA submissions, especially for innovative device types such as In Vitro Diagnostics (IVD), Software as a Medical Device (SaMD), and AI/ML-driven technologies. Engage
HQ:
Canada
Languages:
English, German, Tamil, Hindi
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), De Novo, PMA
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
