Medical Device Academy
Expert FDA 510(k) Regulatory Consulting | Medical Device Academy
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 both in the US and globally. They offer extensive 510(k) consulting, coupled with eSTAR and valuable training courses, ensuring clients achieve successful market clearances.
Buyer Snapshot
Best for
- Medical device companies preparing their first or subsequent 510(k) submissions.
- Teams needing structured training and resources for FDA regulatory pathways.
- Organizations seeking to understand and implement the FDA eSTAR format.
How engagement typically works
- Self-paced learning through courses and eBooks.
- Access to updated resources and ongoing support via email subscriptions.
- Consulting services for specific submission challenges.
Typical deliverables
- 510(k) course materials (webinars, templates, eBook).
- eSTAR templates and training.
- Project management tools and lessons learned.
- Guidance on responding to FDA RTA holds and eCopy issues.
Good to know
- Best when buyers are prepared to subscribe to email updates to receive all content.
- Best when buyers have sufficient Dropbox storage for downloaded materials.
Pricing
Model:
Per SKU
Public range:
Publicly listed: $299 - $1,495
Notes:
Pricing is based on publicly listed information for specific courses and resources.
“Buy the 510k course for $1,495”
HQ:
United States
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Traditional 510(k) Support, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), De Novo
Device Types Supported:
Medical device, IVD
Years Experience:
25
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
Consulting
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Typical Lead Time Weeks:
18
