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
**Who they are**
Akash Kirani is a Regulatory Affairs Expert with over two years of experience in the MedTech industry, focusing on enhancing compliance for medical devices. They are dedicated to simplifying regulatory journeys across international markets.
**Expertise & scope**
* Regulatory Affairs expertise for MedTech companies.
* Focus on enhancing compliance for medical devices.
* Support for navigating international regulatory landscapes.
**Reputation / proof points**
* 2+ Years of MedTech Experience.
Akash Kirani is a Regulatory Affairs Expert with over two years of experience in the MedTech industry, focusing on enhancing compliance for medical devices. They are dedicated to simplifying regulatory journeys across international markets.
**Expertise & scope**
* Regulatory Affairs expertise for MedTech companies.
* Focus on enhancing compliance for medical devices.
* Support for navigating international regulatory landscapes.
**Reputation / proof points**
* 2+ Years of MedTech Experience.
Additional information
For those seeking to simplify their regulatory journey, Akash Kirani offers expertise in MedTech regulatory affairs. They are available to assist medtech companies, regulatory professionals, and potential partners with questions, feedback, or collaboration ideas. The firm emphasizes enhancing compliance for medical devices and navigating international markets. Engagement typically involves direct communication to address specific needs and inquiries.
Key Highlights
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Regulatory Affairs Expert with 2+ Years of MedTech Experience.
Source
“Regulatory Affairs Expert with 2+ Years of MedTech Experience”
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Focuses on enhancing compliance for medical devices.
Source
“Enhancing Compliance for Medical Devices”
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Aims to simplify regulatory journeys across international markets.
Source
“Simplify Your Regulatory Journey Across International Markets”
Buyer Snapshot
Best for
- MedTech companies seeking regulatory compliance expertise.
- Regulatory professionals looking for specialized support.
- Entities needing assistance with international market entry.
How engagement typically works
- Direct communication for inquiries and collaboration.
- Responsive support for questions and feedback.
Typical deliverables
- Regulatory compliance enhancement strategies.
- Guidance on navigating international regulatory requirements.
- Support for MedTech product compliance.
Good to know
- Best when requiring specialized MedTech regulatory affairs support.
- Best when seeking to simplify complex international regulatory processes.
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
