Free Custom RA Proposal

Device Development Proposal

For products that are in development, we offer you a custom proposal to meet FDA Premarket requirements in a timely fashion. Our efficient approach positions your product for a successful launch.

Device Launch Proposal

For products that are Exempt from, or already received FDA Clearance -or- Approval, we offer you a custom proposal for meeting the additional FDA requirements before your product can begin shipping into U.S. markets.

Postmarket Support Proposal

For products that meet FDA Premarket requirements for the U.S., we offer you a custom proposal for long-term sustaining services. This supports both you and your customers to meet FDA Postmarket requirements.

Defining your proposal only takes a few minutes. We will send you full documentation via eMail for internal company review.

Select the specific services (check-boxes) that you will require. Note that you can click on the service name to view a description:

Provide company, contact, and product information:
 U.S. Business Non-U.S. Business
You will receive an invitation to download your custom RA proposal at the eMail address provided. We also provide case tracking and contact information, and you can easily reach us with any questions, concerns, or advice on moving forward.