What services does Akash Kirani offer?

Akash Kirani offers Regulatory Pathway Assessment, 510(k) Submission Authoring, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Akash Kirani specialize in?

Akash Kirani specializes in 510k and other FDA regulatory pathways for medical devices.

What is Akash Kirani's regulatory experience?

Akash Kirani has 3+ years of experience, 3+ 510(k) submissions in FDA regulatory affairs.

Akash Kirani

Regulatory Affairs Consultant

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 sy...

Experience: 3+ years

Submissions: 3 510(k)

Expertise & Specializations

Regulatory Pathways

510k

Regions Served

Akash Kirani provides regulatory consulting services to clients in:

United States (FDA)

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510k

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US
Background: 3+ years of regulatory experience.

Cruxi view

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.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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