Real Time Consulting - FDA Process and Process Tools

The medical world has its own set of standards for certification of medical equipment.

In the U.S, the FDA imposes a set of certification standards governing the approval process of medical devices prior to market availability. Achieving a cost effective project, resulting in an FDA approval, requires a comprehensive understanding of the FDA Regulatory Submittal Process.

• FDA Regulatory Submission Process Expertise
• Project Management
• Requirement Gathering, Definition and Management
• Requirements Traceability Top to Bottom
• Design for Maximum Re-Use, Ease of Testability
• Implementation on Your Target
• Comprehensive Development and End Product Testing
• Documentation Ready for Regulatory Submission

Achieving quick and cost effective certification demands a complete understanding of the certification process and the process tools. At RTC we have teams of FDA experts that will be available to answer technical or process related questions so that your project can successfully be certified on-time and on-budget.

Our team will assist your experts in every step of the development and certification process. From facilitating audits required by the authorities to putting together the final documentation our experts have the knowledge to make certification as easy as possible.

For any specific question, you can contact our office. Our Team will be able to show you how we can immediately start ensuring the success of your project.




	Medical projects Medical devices require regulatory agency approval prior to being used on people in most countries. In-depth understanding of regulatory agency expectations is critical. Success of your project is best assured by capitalizing on RTC's extensive experience developing high reliability products to meet regulatory agency expectations.