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
**Who they are**
ISOplan USA is a regulatory consulting firm specializing in FDA 510(k) submissions for medical devices. They are based in Daytona Beach, Florida.
**Expertise & scope**
* Expert FDA 510(k) Regulatory Consulting for Medical Devices
* Guidance on FDA Class I, Class II, and Class III Medical Devices
* Support for understanding FDA Regulations
* Assistance with Medical Devices Exempt from the 510k Procedure
* Services related to ISO 13485 Certification
* Consulting on the FDA 510(k) Process
**Reputation / proof points**
* ISO 13485 Certification
* FDA 510(k) Consulting
* FDA 510(k) Process
* FDA Medical Device Regulations
* FDA Class I, Class II, Class III Medical Devices
* FDA Regulations
* Medical Devices Exempt from the 510k Procedure
ISOplan USA is a regulatory consulting firm specializing in FDA 510(k) submissions for medical devices. They are based in Daytona Beach, Florida.
**Expertise & scope**
* Expert FDA 510(k) Regulatory Consulting for Medical Devices
* Guidance on FDA Class I, Class II, and Class III Medical Devices
* Support for understanding FDA Regulations
* Assistance with Medical Devices Exempt from the 510k Procedure
* Services related to ISO 13485 Certification
* Consulting on the FDA 510(k) Process
**Reputation / proof points**
* ISO 13485 Certification
* FDA 510(k) Consulting
* FDA 510(k) Process
* FDA Medical Device Regulations
* FDA Class I, Class II, Class III Medical Devices
* FDA Regulations
* Medical Devices Exempt from the 510k Procedure
Additional information
ISOplan USA operates during standard business hours, Monday through Friday, from 10:00 am to 6:00 pm Eastern time. They are closed on Saturdays, Sundays, and holidays. Their services encompass various aspects of FDA medical device regulations, including guidance on different device classes and understanding exemptions from the 510(k) procedure. They also highlight their expertise in ISO 13485 Quality Management System Certification.
Key Highlights
-
Expert FDA 510(k) Regulatory Consulting for Medical Devices
Source
“Expert FDA 510(k) Regulatory Consulting for Medical Devices”
-
Guidance on FDA Class I, Class II, and Class III Medical Devices
Source
“FDA Class I, Class II, Class III Medical Devices”
-
Expertise in ISO 13485 Certification
Source
“ISO 13485 Certification”
Certifications & Trust Signals
-
ISO 13485 Certification
Source
“ISO 13485 Certification”
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA 510(k) submission support
- Companies needing guidance on FDA regulations for various device classes
How engagement typically works
- Consulting on regulatory processes
- Expert guidance on compliance requirements
Typical deliverables
- FDA 510(k) submission strategy and support
- Guidance on device classification and exemptions
- Information on ISO 13485 certification
Good to know
- Business hours are Monday-Friday, 10 AM - 6 PM Eastern Time
HQ:
Daytona Beach, United States
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Special 510(k) Support, Traditional 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Device Types Supported:
Medical device, IVD
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:
Yes
Supports Estar:
No
Supports Rta Remediation:
No
Supports Labeling Review:
No
Provides Submission Project Management:
No
