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, Inc. is a quality and regulatory consulting firm that provides FDA U.S. Agent services. They specialize in assisting medical device companies with regulatory compliance and submissions to the U.S. Food and Drug Administration.
**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.
* Training through 510(k) courses and webinars.
**Reputation / proof points**
* Team members are titled based on the number of cleared 510(k) submissions, with consultants having five or more cleared submissions designated as Sr. Regulatory Consultants.
Medical Device Academy, Inc. is a quality and regulatory consulting firm that provides FDA U.S. Agent services. They specialize in assisting medical device companies with regulatory compliance and submissions to the U.S. Food and Drug Administration.
**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.
* Training through 510(k) courses and webinars.
**Reputation / proof points**
* Team members are titled based on the number of cleared 510(k) submissions, with consultants having five or more cleared submissions designated as Sr. Regulatory Consultants.
Additional information
Medical Device Academy offers specialized training courses, including a comprehensive 510(k) course that includes webinars and templates for FDA eSTAR submissions. They also provide resources on FDA User Fees, detailing costs for fiscal years and potential small business discounts. The firm emphasizes the importance of timely user fee payments to avoid submission holds and assists companies in navigating the FDA registration and listing process, including small business status applications. Their services are designed to help small device companies prepare for and manage FDA regulatory requirements effectively.
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 training courses for 510(k) submissions.
Source
“The 510k course includes 36 new eSTAR webinars, 36+ historical webinars, electronic templates for your next 510k submission”
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Assists with quality system implementation for FDA, ISO 13485, and MDSAP.
Source
“implement quality systems for FDA, ISO 13485, and MDSAP compliance”
Certifications & Trust Signals
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Consultants are titled 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
- Small to medium-sized medical device companies seeking FDA compliance support.
- Companies new to the FDA 510(k) submission process.
- Firms requiring a designated U.S. Agent for FDA interactions.
How engagement typically works
- Consultative approach to regulatory strategy.
- Provision of training and educational resources.
- Direct support for submissions and quality systems.
Typical deliverables
- Completed FDA 510(k) submissions.
- Implemented quality management systems.
- FDA U.S. Agent designation.
- Audit reports and recommendations.
- Training materials and webinar access.
Good to know
- Best when engaging early in the product development lifecycle.
- Requires client cooperation for information gathering and submission preparation.
Pricing
Model:
Per SKU
Public range:
Publicly listed: $299 - $1,495
Notes:
Pricing is based on publicly listed information for courses and specific services.
“Buy the 510k course for $1,495”
HQ:
US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Best 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
Additional us_agent_fda Details
Product Types
Medical Devices
Registration Support
Yes
Onboarding Steps
Requires creation of a user fee account and completion of a 510k user fee cover sheet. Small businesses need a Small Business Decision Number. Qualification for small business status takes 60 days.
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