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 specializing in FDA submissions and compliance. They offer FDA U.S. Agent services, assisting small device companies with regulatory requirements.
**Expertise & scope**
* FDA 510(k) submissions, including preparation using the eSTAR template.
* Quality system implementation for FDA, ISO 13485, and MDSAP compliance.
* Quality system audits.
* FDA U.S. Agent designation services.
* Consulting on regulatory submissions for high-risk medical devices.
* Guidance on FDA User Fees and registration requirements.
**Reputation / proof points**
* Rob Packard has approximately 25 years of experience in the medical device, pharmaceutical, and biotechnology industries.
* The firm has a team of consultants with titles based on the number of successful 510(k) submissions cleared.
Medical Device Academy is a quality and regulatory consulting firm specializing in FDA submissions and compliance. They offer FDA U.S. Agent services, assisting small device companies with regulatory requirements.
**Expertise & scope**
* FDA 510(k) submissions, including preparation using the eSTAR template.
* Quality system implementation for FDA, ISO 13485, and MDSAP compliance.
* Quality system audits.
* FDA U.S. Agent designation services.
* Consulting on regulatory submissions for high-risk medical devices.
* Guidance on FDA User Fees and registration requirements.
**Reputation / proof points**
* Rob Packard has approximately 25 years of experience in the medical device, pharmaceutical, and biotechnology industries.
* The firm has a team of consultants with titles based on the number of successful 510(k) submissions cleared.
Additional information
Medical Device Academy provides comprehensive training and resources for medical device companies navigating FDA regulations. Their services extend to preparing companies for FDA 510(k) submissions using the eSTAR template and implementing robust quality management systems aligned with ISO 13485 and MDSAP standards. They also offer audit services and act as FDA U.S. Agents, facilitating communication with the FDA for foreign manufacturers. Companies seeking to understand and manage FDA user fees will find detailed information and support, including guidance on potential small business discounts and the annual registration fee structure.
Key Highlights
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Specializes in FDA 510(k) submissions using the eSTAR template.
Source
“The 510k course includes 37 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.””
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Provides FDA U.S. Agent services.
Source
“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.”
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Offers implementation of quality systems for FDA, ISO 13485, and MDSAP compliance.
Source
“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.”
Certifications & Trust Signals
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Rob Packard has approximately 25 years of experience in the medical device, pharmaceutical, and biotechnology industries.
Source
“Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries.”
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Consulting team titles are based on the number of successful 510(k) submissions cleared.
Source
“The titles for our FDA 510k consultants are based upon the number of 510k submissions they have submitted and were successfully cleared–not the years of experience.”
Buyer Snapshot
Best for
- Small to medium-sized medical device companies
- Companies needing FDA 510(k) submission support
- Manufacturers requiring an FDA U.S. Agent
How engagement typically works
- Consulting proposals for complex needs
- Introductory calls scheduled via calendly
- Email and phone support for inquiries
Typical deliverables
- FDA 510(k) submission packages
- Implemented Quality Management Systems (QMS)
- Audit reports
- FDA U.S. Agent designation
Good to know
- Best when requiring specialized FDA regulatory expertise for device submissions and compliance.
Pricing
Model:
Per SKU
Public range:
Publicly listed: $299 - $11,423
Notes:
Pricing varies for specific services such as the 510k course ($1,495) and annual FDA registration fees ($11,423).
“The annual FDA Registration fee, which increased by 23.1% to $11,423.”
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
Recall Support:
No
Inspection Support:
No
Additional us_agent_fda Details
Product Types
Medical Devices, High-risk medical devices, Implants, Drug/device combination products
Registration Support
Yes
Onboarding Steps
Clients can schedule introductory calls using a calendly app. For complex needs, a consulting proposal is provided. For the 510k course, an automated email confirms subscription to receive updated content via AWeber email subscriptions.
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