FDAMap
Expert Regulatory Services for Drugs, Biologics, and Devices
FDAMap provides expert regulatory services across drugs, biologics, and devices, offering comprehensive support for navigating the complex FDA landscape. With a decade of experience, they specialize in strategic regulatory planning, risk management, and quality system implementation, ensuring compliance and facilitating market access for a wide range of medical products.
About
FDAMap provides expert regulatory services across drugs, biologics, and devices, offering comprehensive support for navigating the complex FDA landscape. With a decade of experience, they specialize in strategic regulatory planning, risk management, and quality system implementation, ensuring compliance and facilitating market access for a wide range of medical products.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** FDAMap
- **Years of experience:** 10
- **510(k)s submitted (self-reported):** 35
- **Regions served:** US
- **Client types:** sme
- **Location:** United States
- **Availability:** available_now
- **Certifications:** rac-us
### **Cruxi analysis**
- **Strength summary:** Experience with De Novo submissions for novel devices. Global regulatory expertise across multiple markets. Regulatory services across drugs, biologics, and devices
- **Unique value:** Regulatory services across drugs, biologics, and devices
- **Ideal projects:** Best suited for startup to enterprise projects. Specializes in General devices
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, de_novo, investigational_device_exemption, annual_reports
- **Device classes:** class-ii, class-i, class-iii
- **Specialties:** regulatory strategy, risk management, usability engineering, clinical evaluation, preclinical testing, clinical trials, quality system implementation, cardiovascular, radiology, ophthalmic, clinical-chemistry, software-samd, other, hematology, general-hospital, ivd, orthopedic, neurology, dental, anesthesiology, pathology
- **Device panels:** general_surgery, gastroenterology, urology, cardiovascular, orthopedic, neurology, other
- **Regulatory pathways:** 510k, de_novo, pma, pre-submission, breakthrough_devices, humanitarian_device_exemption
- **Type:** firm
- **Company:** FDAMap
- **Years of experience:** 10
- **510(k)s submitted (self-reported):** 35
- **Regions served:** US
- **Client types:** sme
- **Location:** United States
- **Availability:** available_now
- **Certifications:** rac-us
### **Cruxi analysis**
- **Strength summary:** Experience with De Novo submissions for novel devices. Global regulatory expertise across multiple markets. Regulatory services across drugs, biologics, and devices
- **Unique value:** Regulatory services across drugs, biologics, and devices
- **Ideal projects:** Best suited for startup to enterprise projects. Specializes in General devices
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, de_novo, investigational_device_exemption, annual_reports
- **Device classes:** class-ii, class-i, class-iii
- **Specialties:** regulatory strategy, risk management, usability engineering, clinical evaluation, preclinical testing, clinical trials, quality system implementation, cardiovascular, radiology, ophthalmic, clinical-chemistry, software-samd, other, hematology, general-hospital, ivd, orthopedic, neurology, dental, anesthesiology, pathology
- **Device panels:** general_surgery, gastroenterology, urology, cardiovascular, orthopedic, neurology, other
- **Regulatory pathways:** 510k, de_novo, pma, pre-submission, breakthrough_devices, humanitarian_device_exemption
Key Highlights
- Experience with De Novo submissions for novel devices. Global regulatory expertise across multiple markets. Regulatory services across drugs, biologics, and devices
- Regulatory services across drugs, biologics, and devices
Certifications & Trust Signals
- 10 years experience
- 35 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Best suited for startup to enterprise projects. Specializes in General devices
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, De Novo Strategy & Authoring, PMA Strategy & Support
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Years Experience:
10
Num510k Submitted:
35
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general_surgery, gastroenterology, urology, cardiovascular, orthopedic, neurology, other
Technology Types:
samd, ai_ml, mobile_app
Accepting New Clients:
Yes
