ISOplan USA
Expert FDA 510(k) Regulatory Consulting for Medical Devices
ISOplan USA is a dedicated consulting firm specializing in FDA 510(k) regulatory submissions and registrations. We empower medical device companies, particularly startups and SMEs, to successfully navigate the FDA regulatory landscape and achieve timely 510(k) clearances. Our focused expertise ensures a streamlined and efficient path to market for Class I and Class II devices.
About
ISOplan USA is a dedicated consulting firm specializing in FDA 510(k) regulatory submissions and registrations. We empower medical device companies, particularly startups and SMEs, to successfully navigate the FDA regulatory landscape and achieve timely 510(k) clearances. Our focused expertise ensures a streamlined and efficient path to market for Class I and Class II devices.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** ISOplan USA
- **Years of experience:** 12
- **Client types:** startup, sme
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** ISOplan USA offers focused expertise in FDA 510(k) submissions, particularly for Class I and Class II medical devices. With 12 years of experience, they provide specialized consulting services to help medical device companies navigate the 510(k) regulatory pathway. Their specialization in traditional 510(k) submissions, coupled with a fixed-project pricing structure, can provide cost predictability for clients. While their listed specialties are broad ('other'), their website focus suggests a deep understanding of the 510(k) process.
- **Unique value:** ISOplan USA offers focused 510(k) expertise with a fixed-project pricing model, providing cost predictability and specialized guidance for companies seeking efficient and successful Class I and II device clearances.
- **Ideal projects:** The ideal client for ISOplan USA is a small to medium-sized medical device company seeking 510(k) clearance for a Class I or Class II device using the traditional pathway. These companies would benefit from ISOplan USA's focused expertise and fixed-project pricing, allowing for better budget control. Projects involving novel technologies or requiring De Novo or PMA pathways may not be the best fit, as their expertise is centered on traditional 510(k) submissions. Companies seeking assistance with broader regulatory strategies beyond 510(k) may also want to consider firms with a wider service offering.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:11:15 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** other
- **Regulatory pathways:** 510k
- **Type:** firm
- **Company:** ISOplan USA
- **Years of experience:** 12
- **Client types:** startup, sme
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** ISOplan USA offers focused expertise in FDA 510(k) submissions, particularly for Class I and Class II medical devices. With 12 years of experience, they provide specialized consulting services to help medical device companies navigate the 510(k) regulatory pathway. Their specialization in traditional 510(k) submissions, coupled with a fixed-project pricing structure, can provide cost predictability for clients. While their listed specialties are broad ('other'), their website focus suggests a deep understanding of the 510(k) process.
- **Unique value:** ISOplan USA offers focused 510(k) expertise with a fixed-project pricing model, providing cost predictability and specialized guidance for companies seeking efficient and successful Class I and II device clearances.
- **Ideal projects:** The ideal client for ISOplan USA is a small to medium-sized medical device company seeking 510(k) clearance for a Class I or Class II device using the traditional pathway. These companies would benefit from ISOplan USA's focused expertise and fixed-project pricing, allowing for better budget control. Projects involving novel technologies or requiring De Novo or PMA pathways may not be the best fit, as their expertise is centered on traditional 510(k) submissions. Companies seeking assistance with broader regulatory strategies beyond 510(k) may also want to consider firms with a wider service offering.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:11:15 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** other
- **Regulatory pathways:** 510k
Key Highlights
- ISOplan USA offers focused expertise in FDA 510(k) submissions, particularly for Class I and Class II medical devices. With 12 years of experience, they provide specialized consulting services to help medical device companies navigate the 510(k) regulatory pathway. Their specialization in traditional 510(k) submissions, coupled with a fixed-project pricing structure, can provide cost predictability for clients. While their listed specialties are broad ('other'), their website focus suggests a de
- ISOplan USA offers focused 510(k) expertise with a fixed-project pricing model, providing cost predictability and specialized guidance for companies seeking efficient and successful Class I and II device clearances.
Certifications & Trust Signals
- 12 years experience
Buyer Snapshot
Best for
- The ideal client for ISOplan USA is a small to medium-sized medical device company seeking 510(k) clearance for a Class I or Class II device using the traditional pathway. These companies would benefit from ISOplan USA's focused expertise and fixed-project pricing, allowing for better budget control. Projects involving novel technologies or requiring De Novo or PMA pathways may not be the best fit
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy
Pathways Supported:
Traditional 510(k)
Device Types Supported:
Medical device
Supports Predicate Research:
Yes
Years Experience:
12
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Engagement Models:
fixed_fee
Accepting New Clients:
No
