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.
About
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.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Medical Device Academy
- **Years of experience:** 12
- **Regions served:** US
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Medical Device Academy is a highly specialized consulting firm with 12 years of dedicated experience in FDA 510(k) regulatory consulting. Their core strength lies in guiding medical device companies through the 510(k) pathway, specifically for Class I and Class II devices, with a particular focus on general hospital applications. They offer extensive 510(k) consulting, including proficiency with eSTAR submissions, and complement this with valuable training courses, indicating a commitment to both execution and client empowerment. This comprehensive approach, combined with their global service reach, positions them as a robust partner for achieving successful market clearances.
- **Unique value:** Medical Device Academy's unique value stems from its deep, specialized focus on FDA 510(k) for Class I/II devices, coupled with hands-on eSTAR proficiency and a strong emphasis on client education through dedicated training courses. They offer a comprehensive solution that not only navigates the regulatory process but also empowers clients with knowledge.
- **Ideal projects:** The ideal client for Medical Device Academy is a medical device company, likely small to medium-sized, developing Class I or Class II devices, particularly those intended for general hospital use, seeking their initial FDA 510(k) clearance. These clients would benefit from their deep expertise in traditional 510(k) submissions and eSTAR proficiency, potentially also requiring support in establishing or refining their Quality Management System (QMS). Projects best suited involve well-defined 510(k) submission needs, where a fixed-project pricing structure is preferred, and where the client values not just the submission but also the opportunity for internal team training and education on regulatory processes.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:15:25 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, qms
- **Device classes:** class-i, class-ii
- **Specialties:** general-hospital, quality system implementation, quality management systems
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
- **Type:** firm
- **Company:** Medical Device Academy
- **Years of experience:** 12
- **Regions served:** US
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Medical Device Academy is a highly specialized consulting firm with 12 years of dedicated experience in FDA 510(k) regulatory consulting. Their core strength lies in guiding medical device companies through the 510(k) pathway, specifically for Class I and Class II devices, with a particular focus on general hospital applications. They offer extensive 510(k) consulting, including proficiency with eSTAR submissions, and complement this with valuable training courses, indicating a commitment to both execution and client empowerment. This comprehensive approach, combined with their global service reach, positions them as a robust partner for achieving successful market clearances.
- **Unique value:** Medical Device Academy's unique value stems from its deep, specialized focus on FDA 510(k) for Class I/II devices, coupled with hands-on eSTAR proficiency and a strong emphasis on client education through dedicated training courses. They offer a comprehensive solution that not only navigates the regulatory process but also empowers clients with knowledge.
- **Ideal projects:** The ideal client for Medical Device Academy is a medical device company, likely small to medium-sized, developing Class I or Class II devices, particularly those intended for general hospital use, seeking their initial FDA 510(k) clearance. These clients would benefit from their deep expertise in traditional 510(k) submissions and eSTAR proficiency, potentially also requiring support in establishing or refining their Quality Management System (QMS). Projects best suited involve well-defined 510(k) submission needs, where a fixed-project pricing structure is preferred, and where the client values not just the submission but also the opportunity for internal team training and education on regulatory processes.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:15:25 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, qms
- **Device classes:** class-i, class-ii
- **Specialties:** general-hospital, quality system implementation, quality management systems
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
Key Highlights
- Medical Device Academy is a highly specialized consulting firm with 12 years of dedicated experience in FDA 510(k) regulatory consulting. Their core strength lies in guiding medical device companies through the 510(k) pathway, specifically for Class I and Class II devices, with a particular focus on general hospital applications. They offer extensive 510(k) consulting, including proficiency with eSTAR submissions, and complement this with valuable training courses, indicating a commitment to bot
- Medical Device Academy's unique value stems from its deep, specialized focus on FDA 510(k) for Class I/II devices, coupled with hands-on eSTAR proficiency and a strong emphasis on client education through dedicated training courses. They offer a comprehensive solution that not only navigates the regulatory process but also empowers clients with knowledge.
Certifications & Trust Signals
- 12 years experience
Buyer Snapshot
Best for
- The ideal client for Medical Device Academy is a medical device company, likely small to medium-sized, developing Class I or Class II devices, particularly those intended for general hospital use, seeking their initial FDA 510(k) clearance. These clients would benefit from their deep expertise in traditional 510(k) submissions and eSTAR proficiency, potentially also requiring support in establishi
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment
Pathways Supported:
Traditional 510(k)
Device Types Supported:
Medical device
Years Experience:
12
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
fixed_fee
Accepting New Clients:
No
