Akash Kirani
Regulatory Affairs Expert with 2+ Years of MedTech Experience - Enhancing Compliance for Medical Devices
As a Biomedical Engineer with a Master's in Regulatory Affairs, I possess a unique blend of technical expertise and hands-on experience in regulatory affairs, particularly in the medical technology sector. My experience includes preparing 510(k) submissions from start to finish, participating in pre-submission meetings, and interacting directly with the FDA. I have also built quality management systems (QMS) for medical devices from scratch and have hands-on experience with Veeva/QuickVault eQMS.
About
As a Biomedical Engineer with a Master's in Regulatory Affairs, I possess a unique blend of technical expertise and hands-on experience in regulatory affairs, particularly in the medical technology sector. My experience includes preparing 510(k) submissions from start to finish, participating in pre-submission meetings, and interacting directly with the FDA. I have also built quality management systems (QMS) for medical devices from scratch and have hands-on experience with Veeva/QuickVault eQMS.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 3
- **510(k)s submitted (self-reported):** 3
- **Regions served:** US
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Akash Kirani offers a valuable blend of biomedical engineering knowledge and hands-on regulatory affairs experience, particularly in the SaMD space. With 2 years dedicated to MedTech RA & QA, including the preparation of three 510(k) submissions from start to finish and direct interaction with the FDA, he brings practical expertise in navigating the regulatory landscape for software-based medical devices. His experience building QMS systems from scratch, coupled with his familiarity with Veeva/QuickVault eQMS, positions him as a strong asset for companies seeking to establish or improve their quality management processes.
- **Unique value:** Akash offers a unique combination of hands-on 510(k) submission experience for SaMD devices, coupled with practical expertise in building QMS systems, making him a valuable asset for companies navigating the complexities of software-based medical device regulation.
- **Ideal projects:** The ideal project for Akash would involve a Class II SaMD company seeking 510(k) clearance, particularly in the cardiovascular, radiology, IVD, anesthesiology, or pathology fields. Startups or small to medium-sized companies looking to establish a QMS system compliant with ISO 13485 and FDA QMSR would also benefit greatly from his experience. His hands-on experience with Pre-Sub meetings and direct FDA interaction makes him well-suited for projects requiring proactive communication with regulatory bodies.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:10:56 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special
- **Device classes:** class-ii
- **Specialties:** cardiovascular, radiology, ivd, anesthesiology, software-samd, pathology
- **Regulatory pathways:** 510k
- **Type:** independent
- **Years of experience:** 3
- **510(k)s submitted (self-reported):** 3
- **Regions served:** US
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Akash Kirani offers a valuable blend of biomedical engineering knowledge and hands-on regulatory affairs experience, particularly in the SaMD space. With 2 years dedicated to MedTech RA & QA, including the preparation of three 510(k) submissions from start to finish and direct interaction with the FDA, he brings practical expertise in navigating the regulatory landscape for software-based medical devices. His experience building QMS systems from scratch, coupled with his familiarity with Veeva/QuickVault eQMS, positions him as a strong asset for companies seeking to establish or improve their quality management processes.
- **Unique value:** Akash offers a unique combination of hands-on 510(k) submission experience for SaMD devices, coupled with practical expertise in building QMS systems, making him a valuable asset for companies navigating the complexities of software-based medical device regulation.
- **Ideal projects:** The ideal project for Akash would involve a Class II SaMD company seeking 510(k) clearance, particularly in the cardiovascular, radiology, IVD, anesthesiology, or pathology fields. Startups or small to medium-sized companies looking to establish a QMS system compliant with ISO 13485 and FDA QMSR would also benefit greatly from his experience. His hands-on experience with Pre-Sub meetings and direct FDA interaction makes him well-suited for projects requiring proactive communication with regulatory bodies.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:10:56 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special
- **Device classes:** class-ii
- **Specialties:** cardiovascular, radiology, ivd, anesthesiology, software-samd, pathology
- **Regulatory pathways:** 510k
Key Highlights
- Akash Kirani offers a valuable blend of biomedical engineering knowledge and hands-on regulatory affairs experience, particularly in the SaMD space. With 2 years dedicated to MedTech RA & QA, including the preparation of three 510(k) submissions from start to finish and direct interaction with the FDA, he brings practical expertise in navigating the regulatory landscape for software-based medical devices. His experience building QMS systems from scratch, coupled with his familiarity with Veeva/Q
- Akash offers a unique combination of hands-on 510(k) submission experience for SaMD devices, coupled with practical expertise in building QMS systems, making him a valuable asset for companies navigating the complexities of software-based medical device regulation.
Certifications & Trust Signals
- 3 years experience
- 3 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal project for Akash would involve a Class II SaMD company seeking 510(k) clearance, particularly in the cardiovascular, radiology, IVD, anesthesiology, or pathology fields. Startups or small to medium-sized companies looking to establish a QMS system compliant with ISO 13485 and FDA QMSR would also benefit greatly from his experience. His hands-on experience with Pre-Sub meetings and direc
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Predicate Research & Substantial Equivalence Strategy, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Device Types Supported:
IVD, SaMD, Medical device
Years Experience:
3
Num510k Submitted:
3
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Technology Types:
samd
Engagement Models:
hourly
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Provides Submission Project Management:
Yes
