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**
medicaldeviceacademy.com provides consulting and training services focused on FDA regulatory compliance for medical technology companies. They assist both startups and established firms in navigating complex FDA processes.
**Expertise & scope**
* Expert consulting and training for FDA 510(k) submissions.
* Guidance on Quality Management Systems (QMS) and regulatory compliance.
* Assistance with bringing safer, more effective devices to market.
* Support for FDA User Fees, including understanding and payment processes.
* Guidance on FDA registration and listing for medical devices.
* Training on FDA eSTAR templates and submission preparation.
**Reputation / proof points**
* Consultants are titled based on the number of successfully cleared 510(k) submissions, with Sr. Regulatory Consultants having five or more.
medicaldeviceacademy.com provides consulting and training services focused on FDA regulatory compliance for medical technology companies. They assist both startups and established firms in navigating complex FDA processes.
**Expertise & scope**
* Expert consulting and training for FDA 510(k) submissions.
* Guidance on Quality Management Systems (QMS) and regulatory compliance.
* Assistance with bringing safer, more effective devices to market.
* Support for FDA User Fees, including understanding and payment processes.
* Guidance on FDA registration and listing for medical devices.
* Training on FDA eSTAR templates and submission preparation.
**Reputation / proof points**
* Consultants are titled based on the number of successfully cleared 510(k) submissions, with Sr. Regulatory Consultants having five or more.
Additional information
medicaldeviceacademy.com offers a comprehensive 510(k) course that includes webinars, electronic templates, and an eBook. This course is designed to keep users updated with evolving FDA requirements for 510(k) and De Novo submissions. They also provide specific training on FDA eSTAR templates. For those who previously purchased the FDA PreSTAR tutorial, a credit is available towards the 510(k) course. The company emphasizes that updated content is delivered via email subscriptions, requiring user confirmation to receive these updates.
Key Highlights
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Offers expert consulting and training for FDA 510(k) submissions.
Source
“Medical Device Academy offers expert consulting and training for FDA 510(k) submissions, Quality Management Systems (QMS), and regulatory compliance.”
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Provides guidance on Quality Management Systems (QMS) and regulatory compliance.
Source
“Medical Device Academy offers expert consulting and training for FDA 510(k) submissions, Quality Management Systems (QMS), and regulatory compliance.”
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Assists companies in navigating complex FDA processes to bring devices to market.
Source
“They assist MedTech startups and established companies in navigating complex FDA processes to bring safer, more effective devices to market.”
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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”
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Offers a 510(k) course with webinars, templates, and an eBook.
Source
“The 510k course includes 36 new eSTAR webinars, 36+ historical webinars, electronic templates for your next 510k submission, and the eBook “How to Prepare a 510(k) in 100 days.””
Buyer Snapshot
Best for
- Medical device startups and established companies needing FDA regulatory guidance.
- Companies seeking assistance with 510(k) submissions and QMS.
- Firms requiring training on FDA processes and documentation.
How engagement typically works
- Consulting services for specific regulatory challenges.
- Training courses and webinars for teams.
- Provision of templates and resources for self-guided preparation.
Typical deliverables
- FDA 510(k) submission strategy and support.
- QMS development and implementation guidance.
- Regulatory compliance training materials.
- FDA registration and listing assistance.
- Updated webinars and templates for 510(k) submissions.
Good to know
- Best when engaging with complex FDA submission processes.
- Requires active participation in email subscriptions for content updates.
Pricing
Model:
Per SKU
Public range:
Publicly listed: $299 - $1,495
Notes:
Pricing is based on publicly listed course and tutorial fees. Actual consulting fees may vary.
“Buy the 510k course for $1,495”
HQ:
US
Languages:
English
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 creating a user fee account and paying Device Facility User Fee (DFUF) before submission. Small businesses need to apply for status annually using FDA Form 3602 or 3602A.
