Sathavahana Valiveti
Expert SaMD & AI/ML Regulatory Strategist | FDA 510(k), PMA, EU MDR/IVDR | 8+ Years Experience
Accomplished and driven Regulatory Affairs Specialist with over 8 years of comprehensive experience in navigating the complex landscape of medical device regulatory strategy. Dr. Valiveti possesses specialized expertise in Software as a Medical Device (SaMD), adeptly managing FDA 510(k) and PMA submissions, as well as EU MDR and IVDR compliance. Their collaborative approach with engineering teams ensures robust regulatory strategies for AI-enabled and cloud-native medical software, from initial development through post-market surveillance. With a proven track record of authoring critical pre-market submissions and post-market documentation for global market access, and a keen eye for Ad-Promo review and QMS management, Dr. Valiveti is a valuable asset for any medtech company seeking to bring innovative solutions to market efficiently and compliantly.
About
Accomplished and driven Regulatory Affairs Specialist with over 8 years of comprehensive experience in navigating the complex landscape of medical device regulatory strategy. Dr. Valiveti possesses specialized expertise in Software as a Medical Device (SaMD), adeptly managing FDA 510(k) and PMA submissions, as well as EU MDR and IVDR compliance. Their collaborative approach with engineering teams ensures robust regulatory strategies for AI-enabled and cloud-native medical software, from initial development through post-market surveillance. With a proven track record of authoring critical pre-market submissions and post-market documentation for global market access, and a keen eye for Ad-Promo review and QMS management, Dr. Valiveti is a valuable asset for any medtech company seeking to bring innovative solutions to market efficiently and compliantly.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 8
- **510(k)s submitted (self-reported):** 25
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC
- **Client types:** sme, large_medtech
- **Location:** United States (PA)
- **Availability:** available_now
- **Certifications:** Certified Regulatory Affairs Specialist - US
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### **Cruxi analysis**
- **Strength summary:** With over 8 years of dedicated experience, Sathavahana Valiveti stands out as a formidable Regulatory Affairs Specialist with deep expertise in navigating the complex regulatory landscape for medical devices, particularly in the burgeoning field of Software as a Medical Device (SaMD) and AI/ML technologies. Their comprehensive experience spans critical FDA pathways, including successful 510(k) and PMA submissions, alongside adept management of EU MDR and IVDR compliance, making them exceptionally valuable for medtech companies targeting both US and European markets. Dr. Valiveti's proven track record in authoring pre-market submissions, managing post-market surveillance, and ensuring Ad-Promo compliance, coupled with their collaborative approach with engineering teams, significantly de-risks the product development lifecycle. Their strong foundation in QMS management and adherence to international standards like ISO 13485 and ISO 14971 further solidify their ability to drive efficient and compliant market access for innovative medtech solutions.
- **Unique value:** Sathavahana Valiveti offers a rare and powerful combination of deep technical understanding in SaMD and AI/ML, coupled with a proven, hands-on track record across multiple critical FDA and EU regulatory pathways. Their ability to bridge the gap between cutting-edge technology and stringent regulatory requirements, honed through experience at leading medtech firms, makes them an indispensable asset for companies looking to accelerate innovation with confidence and compliance.
- **Ideal projects:** This consultant is ideally suited for medtech companies, from SMEs to large enterprises, developing innovative Software as a Medical Device (SaMD) or AI/ML-enabled medical software. They are particularly valuable for projects requiring robust FDA 510(k), PMA, or de novo strategy development, as well as EU MDR/IVDR compliance efforts. Companies seeking expertise in global market access, especially for Class II and Class III devices within the IVD and wearable digital sectors, will find Dr. Valiveti to be an exceptional partner. Engaging them early in the product development lifecycle, from initial regulatory strategy and pathway assessment through to QMS setup and post-market surveillance, will maximize their impact and ensure a streamlined, compliant launch.
- **Last analyzed:** Sat Dec 20 2025 01:55:16 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, qms, international
- **Device classes:** class-ii, class-iii
- **Specialties:** software-samd, ivd, other, regulatory strategy, quality management systems, risk management
- **Device panels:** ivd, wearable_digital, other
- **Regulatory pathways:** 510k, pma, q_sub, post_market
---
- **Type:** independent
- **Years of experience:** 8
- **510(k)s submitted (self-reported):** 25
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC
- **Client types:** sme, large_medtech
- **Location:** United States (PA)
- **Availability:** available_now
- **Certifications:** Certified Regulatory Affairs Specialist - US
---
### **Cruxi analysis**
- **Strength summary:** With over 8 years of dedicated experience, Sathavahana Valiveti stands out as a formidable Regulatory Affairs Specialist with deep expertise in navigating the complex regulatory landscape for medical devices, particularly in the burgeoning field of Software as a Medical Device (SaMD) and AI/ML technologies. Their comprehensive experience spans critical FDA pathways, including successful 510(k) and PMA submissions, alongside adept management of EU MDR and IVDR compliance, making them exceptionally valuable for medtech companies targeting both US and European markets. Dr. Valiveti's proven track record in authoring pre-market submissions, managing post-market surveillance, and ensuring Ad-Promo compliance, coupled with their collaborative approach with engineering teams, significantly de-risks the product development lifecycle. Their strong foundation in QMS management and adherence to international standards like ISO 13485 and ISO 14971 further solidify their ability to drive efficient and compliant market access for innovative medtech solutions.
- **Unique value:** Sathavahana Valiveti offers a rare and powerful combination of deep technical understanding in SaMD and AI/ML, coupled with a proven, hands-on track record across multiple critical FDA and EU regulatory pathways. Their ability to bridge the gap between cutting-edge technology and stringent regulatory requirements, honed through experience at leading medtech firms, makes them an indispensable asset for companies looking to accelerate innovation with confidence and compliance.
- **Ideal projects:** This consultant is ideally suited for medtech companies, from SMEs to large enterprises, developing innovative Software as a Medical Device (SaMD) or AI/ML-enabled medical software. They are particularly valuable for projects requiring robust FDA 510(k), PMA, or de novo strategy development, as well as EU MDR/IVDR compliance efforts. Companies seeking expertise in global market access, especially for Class II and Class III devices within the IVD and wearable digital sectors, will find Dr. Valiveti to be an exceptional partner. Engaging them early in the product development lifecycle, from initial regulatory strategy and pathway assessment through to QMS setup and post-market surveillance, will maximize their impact and ensure a streamlined, compliant launch.
- **Last analyzed:** Sat Dec 20 2025 01:55:16 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, qms, international
- **Device classes:** class-ii, class-iii
- **Specialties:** software-samd, ivd, other, regulatory strategy, quality management systems, risk management
- **Device panels:** ivd, wearable_digital, other
- **Regulatory pathways:** 510k, pma, q_sub, post_market
---
Key Highlights
- With over 8 years of dedicated experience, Sathavahana Valiveti stands out as a formidable Regulatory Affairs Specialist with deep expertise in navigating the complex regulatory landscape for medical devices, particularly in the burgeoning field of Software as a Medical Device (SaMD) and AI/ML technologies. Their comprehensive experience spans critical FDA pathways, including successful 510(k) and PMA submissions, alongside adept management of EU MDR and IVDR compliance, making them exceptionall
- Sathavahana Valiveti offers a rare and powerful combination of deep technical understanding in SaMD and AI/ML, coupled with a proven, hands-on track record across multiple critical FDA and EU regulatory pathways. Their ability to bridge the gap between cutting-edge technology and stringent regulatory requirements, honed through experience at leading medtech firms, makes them an indispensable asset for companies looking to accelerate innovation with confidence and compliance.
Certifications & Trust Signals
- 8 years experience
- 25 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- This consultant is ideally suited for medtech companies, from SMEs to large enterprises, developing innovative Software as a Medical Device (SaMD) or AI/ML-enabled medical software. They are particularly valuable for projects requiring robust FDA 510(k), PMA, or de novo strategy development, as well as EU MDR/IVDR compliance efforts. Companies seeking expertise in global market access, especially
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), PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
8
Num510k Submitted:
25
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd, wearable_digital, other
Technology Types:
samd, ai_ml, cloud_platform
Accepting New Clients:
No
