Medical Device Academy
Medical Device Academy, Inc.
Medical Device Academy, Inc. is a quality and regulatory consulting firm specializing in FDA 510(k) submissions, quality system implementation, and FDA US Agent services. They help small device companies prepare FDA 510(k) submissions using the eSTAR template, implement quality systems for FDA, ISO 13485, and MDSAP compliance, conduct quality system audits, and provide FDA US Agent designation services.
Medical Device Academy, Inc. is a quality and regulatory consulting firm with a team of ten professionals working virtually. They specialize in helping small device companies prepare FDA 510(k) submissions using the eSTAR template, preparing FDA pre-submissions using the PreSTAR template, implementing new quality systems for compliance with FDA, ISO 13485, and MDSAP, and conducting quality system audits. Their services include FDA US Agent services, CE Marking preparation, Canadian License applications, and regulatory pathway analysis for US, European, and Canadian markets. They also provide training courses and webinars for medical device professionals. Clients with urgent needs where time to market is critical turn to Medical Device Academy for their expertise in FDA regulations and quality systems.
About
**Who they are**
Medical Device Academy is a quality and regulatory consulting firm that offers specialized services for medical device companies navigating FDA requirements. They focus on providing expertise in areas such as FDA 510(k) submissions, quality system implementation, and FDA U.S. Agent services.
**Expertise & scope**
* FDA 510(k) submissions, including preparation using the eSTAR template.
* Quality system implementation for FDA, ISO 13485, and MDSAP compliance.
* Conducting quality system audits.
* Providing FDA U.S. Agent designation services.
* Guidance on FDA user fees and registration processes.
* Development of regulatory strategies and documentation.
**Reputation / proof points**
* Offers a 510(k) course with webinars and templates for submissions.
* Provides a book titled "How to Prepare Your 510k in 100 days."
Medical Device Academy is a quality and regulatory consulting firm that offers specialized services for medical device companies navigating FDA requirements. They focus on providing expertise in areas such as FDA 510(k) submissions, quality system implementation, and FDA U.S. Agent services.
**Expertise & scope**
* FDA 510(k) submissions, including preparation using the eSTAR template.
* Quality system implementation for FDA, ISO 13485, and MDSAP compliance.
* Conducting quality system audits.
* Providing FDA U.S. Agent designation services.
* Guidance on FDA user fees and registration processes.
* Development of regulatory strategies and documentation.
**Reputation / proof points**
* Offers a 510(k) course with webinars and templates for submissions.
* Provides a book titled "How to Prepare Your 510k in 100 days."
Additional information
Medical Device Academy assists companies with critical FDA processes, including the preparation and submission of 510(k) applications. They emphasize the use of the eSTAR template for submissions and offer comprehensive support for quality system implementation to meet standards like ISO 13485 and MDSAP. For companies requiring an official U.S. Agent, they provide designation services. Their expertise extends to navigating FDA user fees, establishment registration, and device listing requirements, offering practical guidance to ensure compliance and facilitate market access for medical devices.
Key Highlights
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Specializes in FDA 510(k) submissions using the eSTAR template.
Source
“Medical Device Academy, Inc. is a quality and regulatory consulting firm specializing in FDA 510(k) submissions”
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Provides FDA U.S. Agent designation services.
Source
“and provide FDA US Agent designation services.”
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Offers comprehensive support for quality system implementation (FDA, ISO 13485, MDSAP).
Source
“implement quality systems for FDA, ISO 13485, and MDSAP compliance”
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Provides a 510(k) course with webinars and templates.
Source
“The 510k course includes 37 new eSTAR webinars, 36+ historical webinars, electronic templates for your next 510k submission”
Certifications & Trust Signals
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Consultant titles are based on the number of successfully cleared 510(k) submissions.
Source
“The titles for our FDA 510k consultants are based upon the number of 510k submissions they have submitted and were successfully cleared”
Buyer Snapshot
Best for
- Companies seeking FDA 510(k) submission assistance.
- Firms needing to implement or audit quality management systems (ISO 13485, MDSAP).
- Businesses requiring an FDA U.S. Agent.
How engagement typically works
- Consulting services for regulatory submissions.
- Training courses and resources for compliance.
- Direct support for FDA registration and user fees.
Typical deliverables
- FDA 510(k) submission packages.
- Implemented quality management systems.
- FDA U.S. Agent designation.
- Audit reports.
- Training materials and webinars.
Good to know
- Best when companies need specialized FDA regulatory expertise for medical devices.
Pricing
Model:
Per SKU
Public range:
Publicly listed: $299 - $1,495
Notes:
Pricing is based on publicly listed information for specific courses and resources; final fees may vary based on scope.
“Buy the 510k course for $1,495”
HQ:
US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Annual Renewal Support:
Yes
Registration Support:
Yes
Emergency Contact24x7:
No
Annual Renewal Reminder:
No
Product Type:
devices
Recall Support:
No
Inspection Support:
No
Additional us_agent_fda Details
Product Types
Medical Devices
Registration Support
Yes
Onboarding Steps
Companies may need to create a user fee account and pay the Device Facility User Fee (DFUF) prior to submission. Small businesses should apply for small business status by completing FDA Form 3602 or 3602A with tax returns.
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