Seshasena Reddy Muli
Regulatory Affairs & Quality Specialist for Medical Devices. Expertise in FDA/Health Canada submissions, QMS (ISO...
A highly motivated regulatory and quality professional with a Master of Science in Regulatory Affairs from Northeastern University (GPA 4.0) and a clinical background as a Doctor of Pharmacy. Possesses hands-on experience in developing comprehensive regulatory strategies for Class II medical devices, from concept through to FDA submission, and authoring regulatory pathways for international markets like Canada. Expertise includes in-depth knowledge of FDA regulations (21 CFR 820), cGMP, Quality System Regulation (QSR), and international standards such as ISO 13485 and ISO 14971. Proven ability in Quality Assurance, including CAPA management, change control, and SOP authoring. Combines rigorous academic training with practical experience in cross-functional collaboration, making them a valuable asset for medtech companies seeking efficient and compliant market access.
About
A highly motivated regulatory and quality professional with a Master of Science in Regulatory Affairs from Northeastern University (GPA 4.0) and a clinical background as a Doctor of Pharmacy. Possesses hands-on experience in developing comprehensive regulatory strategies for Class II medical devices, from concept through to FDA submission, and authoring regulatory pathways for international markets like Canada. Expertise includes in-depth knowledge of FDA regulations (21 CFR 820), cGMP, Quality System Regulation (QSR), and international standards such as ISO 13485 and ISO 14971. Proven ability in Quality Assurance, including CAPA management, change control, and SOP authoring. Combines rigorous academic training with practical experience in cross-functional collaboration, making them a valuable asset for medtech companies seeking efficient and compliant market access.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 2
- **Regions served:** US, CA
- **Client types:** startup, sme
- **Location:** United States (MA)
- **Availability:** available_now
- **Certifications:** Licensed Pharmacy Trainee Technician, GCP for Clinical Trials with Investigational Drugs and Medical Devices, CPR, BLS, AED Certification
---
### **Cruxi analysis**
- **Strength summary:** Seshasena Reddy Muli offers a powerful combination of elite academic training and targeted hands-on experience ideal for medtech innovators. With a Master's in Regulatory Affairs (4.0 GPA) from Northeastern and a clinical Doctor of Pharmacy background, they possess a rare, dual perspective on product development. Their 2 years of focused experience have been spent developing comprehensive regulatory strategies for Class II medical devices, including authoring pathways for both the US FDA and Health Canada. This consultant excels in building regulatory compliance from the ground up, with deep expertise in QMS (21 CFR 820, ISO 13485), risk management (ISO 14971), and authoring 510(k) submission strategies, making them an exceptionally sharp and valuable asset for navigating the crucial early stages of market access.
- **Unique value:** This consultant's key differentiator is the powerful synthesis of a clinical Doctor of Pharmacy degree with a high-achieving Master's in Regulatory Affairs. This unique blend provides a holistic understanding of a device's entire lifecycle, from its clinical application and patient impact to the intricate details of regulatory compliance. This dual expertise is especially valuable for companies developing combination products or devices with complex clinical use cases, ensuring strategies are not just compliant, but also clinically robust and defensible.
- **Ideal projects:** The ideal client is a startup or small-to-medium-sized medtech company developing a Class II device, particularly in the orthopedic, general surgery, or wearable technology space. This consultant is perfectly suited for companies preparing for their first 510(k) submission or seeking to expand into the Canadian market. They thrive on projects requiring the development of a complete regulatory and quality strategy from concept to submission, including QMS setup, predicate analysis, and full submission authoring. Engaging this consultant early in the design phase would be highly strategic to ensure a seamless and compliant pathway to commercialization.
- **Last analyzed:** Mon Dec 22 2025 19:02:02 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, qms, international
- **Device classes:** class-ii
- **Specialties:** orthopedic, general-hospital, other
- **Device panels:** orthopedic, obgyn, general_surgery
- **Regulatory pathways:** 510k, pma, ide
---
- **Type:** independent
- **Years of experience:** 2
- **Regions served:** US, CA
- **Client types:** startup, sme
- **Location:** United States (MA)
- **Availability:** available_now
- **Certifications:** Licensed Pharmacy Trainee Technician, GCP for Clinical Trials with Investigational Drugs and Medical Devices, CPR, BLS, AED Certification
---
### **Cruxi analysis**
- **Strength summary:** Seshasena Reddy Muli offers a powerful combination of elite academic training and targeted hands-on experience ideal for medtech innovators. With a Master's in Regulatory Affairs (4.0 GPA) from Northeastern and a clinical Doctor of Pharmacy background, they possess a rare, dual perspective on product development. Their 2 years of focused experience have been spent developing comprehensive regulatory strategies for Class II medical devices, including authoring pathways for both the US FDA and Health Canada. This consultant excels in building regulatory compliance from the ground up, with deep expertise in QMS (21 CFR 820, ISO 13485), risk management (ISO 14971), and authoring 510(k) submission strategies, making them an exceptionally sharp and valuable asset for navigating the crucial early stages of market access.
- **Unique value:** This consultant's key differentiator is the powerful synthesis of a clinical Doctor of Pharmacy degree with a high-achieving Master's in Regulatory Affairs. This unique blend provides a holistic understanding of a device's entire lifecycle, from its clinical application and patient impact to the intricate details of regulatory compliance. This dual expertise is especially valuable for companies developing combination products or devices with complex clinical use cases, ensuring strategies are not just compliant, but also clinically robust and defensible.
- **Ideal projects:** The ideal client is a startup or small-to-medium-sized medtech company developing a Class II device, particularly in the orthopedic, general surgery, or wearable technology space. This consultant is perfectly suited for companies preparing for their first 510(k) submission or seeking to expand into the Canadian market. They thrive on projects requiring the development of a complete regulatory and quality strategy from concept to submission, including QMS setup, predicate analysis, and full submission authoring. Engaging this consultant early in the design phase would be highly strategic to ensure a seamless and compliant pathway to commercialization.
- **Last analyzed:** Mon Dec 22 2025 19:02:02 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, qms, international
- **Device classes:** class-ii
- **Specialties:** orthopedic, general-hospital, other
- **Device panels:** orthopedic, obgyn, general_surgery
- **Regulatory pathways:** 510k, pma, ide
---
Key Highlights
- Seshasena Reddy Muli offers a powerful combination of elite academic training and targeted hands-on experience ideal for medtech innovators. With a Master's in Regulatory Affairs (4.0 GPA) from Northeastern and a clinical Doctor of Pharmacy background, they possess a rare, dual perspective on product development. Their 2 years of focused experience have been spent developing comprehensive regulatory strategies for Class II medical devices, including authoring pathways for both the US FDA and Hea
- This consultant's key differentiator is the powerful synthesis of a clinical Doctor of Pharmacy degree with a high-achieving Master's in Regulatory Affairs. This unique blend provides a holistic understanding of a device's entire lifecycle, from its clinical application and patient impact to the intricate details of regulatory compliance. This dual expertise is especially valuable for companies developing combination products or devices with complex clinical use cases, ensuring strategies are no
Certifications & Trust Signals
- 2 years experience
Buyer Snapshot
Best for
- The ideal client is a startup or small-to-medium-sized medtech company developing a Class II device, particularly in the orthopedic, general surgery, or wearable technology space. This consultant is perfectly suited for companies preparing for their first 510(k) submission or seeking to expand into the Canadian market. They thrive on projects requiring the development of a complete regulatory and
HQ:
United States
Languages:
English
Status:
claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support
Pathways Supported:
Traditional 510(k), PMA
Device Types Supported:
Medical device
Supports Predicate Research:
Yes
Years Experience:
2
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
orthopedic, obgyn, general_surgery
Technology Types:
wearable_patch, combo_product
Accepting New Clients:
Yes
