Sravanthi Polavarapu
Regulatory Affairs Expert - Medtech Compliance & Strategy
Regulatory affairs expert with experience in FDA submissions, medical device compliance, and global regulatory strategies. Skilled in QMS, ISO 13485, and quality systems. Proven track record of success in navigating complex regulatory landscapes and driving business growth. Contact for quote for comprehensive regulatory services.
About
Regulatory affairs expert with experience in FDA submissions, medical device compliance, and global regulatory strategies. Skilled in QMS, ISO 13485, and quality systems. Proven track record of success in navigating complex regulatory landscapes and driving business growth. Contact for quote for comprehensive regulatory services.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 5
- **510(k)s submitted (self-reported):** 1
- **Ex-Big MedTech:** Yes
- **Regions served:** US, CA
- **Client types:** large_medtech, startup, sme
- **Location:** United States (New Jersey)
- **Availability:** available_now
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### **Cruxi analysis**
- **Strength summary:** Sravanthi Polavarapu offers a potent combination of specialized expertise and big-medtech experience, making her an invaluable asset for diagnostic companies. With 5 years focused on the IVD space, her background at Siemens Healthineers provides deep insight into navigating complex quality systems and product development lifecycles. Her proven track record, including managing multiple FDA pre-submissions and successfully achieving Health Canada clearance for Class II assays, demonstrates a clear ability to execute on critical regulatory milestones. This practical success, underpinned by a specialized Master's degree in Regulatory Affairs from Johns Hopkins, makes her a highly strategic partner for medtech companies seeking to navigate the FDA's 510(k) pathway and enter the North American market.
- **Unique value:** Sravanthi's unique value lies in her deep specialization in IVD diagnostics, combining hands-on experience from a global medtech leader with a proven ability to secure market clearance in both the US and Canada. This dual-market expertise, especially her success with Health Canada, provides a distinct advantage for companies with North American commercialization strategies. Her focused skill set ensures clients receive expert, relevant guidance tailored specifically to the challenges of the diagnostics industry.
- **Ideal projects:** The ideal project for Sravanthi is with a startup or SME developing a Class I or Class II IVD device, particularly in the clinical chemistry or hematology space. She is perfectly suited for companies preparing for their first 510(k) submission, needing expert guidance on a Q-Sub strategy to de-risk their FDA engagement, or seeking to expand into the Canadian market. Medtech firms looking to establish or refine their QMS to meet ISO 13485 standards would also greatly benefit from her expertise. Engaging her early in the development process for pathway assessment and test strategy would maximize her strategic value and ensure a smoother path to market.
- **Last analyzed:** Mon Dec 22 2025 14:29:43 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-ii, class-i
- **Specialties:** ivd, general-hospital, clinical-chemistry, hematology
- **Device panels:** ivd, other
- **Regulatory pathways:** 510k, q_sub, post_market
---
- **Type:** independent
- **Years of experience:** 5
- **510(k)s submitted (self-reported):** 1
- **Ex-Big MedTech:** Yes
- **Regions served:** US, CA
- **Client types:** large_medtech, startup, sme
- **Location:** United States (New Jersey)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** Sravanthi Polavarapu offers a potent combination of specialized expertise and big-medtech experience, making her an invaluable asset for diagnostic companies. With 5 years focused on the IVD space, her background at Siemens Healthineers provides deep insight into navigating complex quality systems and product development lifecycles. Her proven track record, including managing multiple FDA pre-submissions and successfully achieving Health Canada clearance for Class II assays, demonstrates a clear ability to execute on critical regulatory milestones. This practical success, underpinned by a specialized Master's degree in Regulatory Affairs from Johns Hopkins, makes her a highly strategic partner for medtech companies seeking to navigate the FDA's 510(k) pathway and enter the North American market.
- **Unique value:** Sravanthi's unique value lies in her deep specialization in IVD diagnostics, combining hands-on experience from a global medtech leader with a proven ability to secure market clearance in both the US and Canada. This dual-market expertise, especially her success with Health Canada, provides a distinct advantage for companies with North American commercialization strategies. Her focused skill set ensures clients receive expert, relevant guidance tailored specifically to the challenges of the diagnostics industry.
- **Ideal projects:** The ideal project for Sravanthi is with a startup or SME developing a Class I or Class II IVD device, particularly in the clinical chemistry or hematology space. She is perfectly suited for companies preparing for their first 510(k) submission, needing expert guidance on a Q-Sub strategy to de-risk their FDA engagement, or seeking to expand into the Canadian market. Medtech firms looking to establish or refine their QMS to meet ISO 13485 standards would also greatly benefit from her expertise. Engaging her early in the development process for pathway assessment and test strategy would maximize her strategic value and ensure a smoother path to market.
- **Last analyzed:** Mon Dec 22 2025 14:29:43 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-ii, class-i
- **Specialties:** ivd, general-hospital, clinical-chemistry, hematology
- **Device panels:** ivd, other
- **Regulatory pathways:** 510k, q_sub, post_market
---
Key Highlights
- Sravanthi Polavarapu offers a potent combination of specialized expertise and big-medtech experience, making her an invaluable asset for diagnostic companies. With 5 years focused on the IVD space, her background at Siemens Healthineers provides deep insight into navigating complex quality systems and product development lifecycles. Her proven track record, including managing multiple FDA pre-submissions and successfully achieving Health Canada clearance for Class II assays, demonstrates a clear
- Sravanthi's unique value lies in her deep specialization in IVD diagnostics, combining hands-on experience from a global medtech leader with a proven ability to secure market clearance in both the US and Canada. This dual-market expertise, especially her success with Health Canada, provides a distinct advantage for companies with North American commercialization strategies. Her focused skill set ensures clients receive expert, relevant guidance tailored specifically to the challenges of the diag
Certifications & Trust Signals
- 5 years experience
- 1 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal project for Sravanthi is with a startup or SME developing a Class I or Class II IVD device, particularly in the clinical chemistry or hematology space. She is perfectly suited for companies preparing for their first 510(k) submission, needing expert guidance on a Q-Sub strategy to de-risk their FDA engagement, or seeking to expand into the Canadian market. Medtech firms looking to establ
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, 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), Pre-Sub / Q-Sub
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
5
Num510k Submitted:
1
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd, other
Technology Types:
ivd_test
Engagement Models:
hourly
Accepting New Clients:
No
