What services does Medical Device Academy offer?

Medical Device Academy offers Regulatory Pathway Assessment, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Medical Device Academy specialize in?

Medical Device Academy specializes in 510k and other FDA regulatory pathways for medical devices.

What is Medical Device Academy's regulatory experience?

Medical Device Academy has 12+ years of experience in FDA regulatory affairs.

Medical Device Academy

Regulatory Consultant

Medical Device Academy is a premier consulting firm exclusively dedicated to FDA 510(k) regulatory consulting. With 12 years of experience, they specialize in guiding medical device companies through the complexities of the FDA regulatory landscape, particularly for 510(k) submissions. Their expertise encompasses traditional 510(k) submissions and Quality Management Systems (QMS), serving clients ...

Experience: 12+ years

Expertise & Specializations

Regulatory Pathways

510k

Device Specialties

General-Hospital

Regions Served

Medical Device Academy provides regulatory consulting services to clients in:

United States (FDA)

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510k

Device Specialties

General-Hospital

Services Offered

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

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: 12+ years of regulatory experience.

Cruxi view

Medical Device Academy is a highly specialized consulting firm with 12 years of dedicated experience in FDA 510(k) regulatory consulting. Their core strength lies in guiding medical device companies through the 510(k) pathway, specifically for Class I and Class II devices, with a particular focus on general hospital applications. They offer extensive 510(k) consulting, including proficiency with eSTAR submissions, and complement this with valuable training courses, indicating a commitment to both execution and client empowerment. This comprehensive approach, combined with their global service reach, positions them as a robust partner for achieving successful market clearances.

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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