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.
Regulatory Affairs Outsource
Specializing in software-enabled medical devices, we partner with you at any phase of the product life-cycle, and provide full service for meeting all FDA Regulatory Requirements.A Passport to Grow Your Market
Market research, intended use, device classification, and full strategy for FDA submissions.
Create Quality Process, Documentation, and SOPs. Provide comprehensive quality and regulatory training.
Internal, pre-certification, and mock FDA audits with gap analysis. Manage external audits.
FDA Premarket Approval
Prepare applicable FDA submission packages. Liaison with FDA to secure product approval.
FDA registration, device listing, official correspondence, and U.S. Agent service. Product Labeling review and compliance (UDI).
Monitoring of all FDA required records, files, and submissions. Continuous improvement process.
Free Custom RA Proposal
It is ultra-convenient to evaluate whether we can fulfill your Regulatory Affairs Partner needs. Based on where you are in the life-cycle for your device, we will create a proposal for you. Your customized proposal is ready to download and evaluate in minutes, and there is no obligation.
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.
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.
FDA Regulatory Guidance
The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices, and the frequent electronic exchange of medical device-related health information.
U.S. FDACybersecurity RegulationsLearn more
FDA has established and continues to implement a unique device identification system to adequately identify medical devices through their distribution and use. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database.
U.S. FDAUDI RegulationsLearn more
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA.
U.S. FDARegistration and ListingLearn more