Clinical & Regulatory Support

Clinical & Regulatory Assistance

Your Foundation for Clinical & Regulatory Success

With the challenging and ever-changing nature of today’s clinical and regulatory environment, many OEMs and start-ups seek third-party assistance to provide clinical builds and regulatory support for their device. Cirtec can help. We can save you time and resources by providing the services, technology, and staff you need to help maneuver through this complex process.

Cirtec brings decades of expertise in customizing design and test programs. As a result, we can help you achieve faster and more predictable success when navigating regulatory approvals under FDA, EMEA and other internationally recognized standards agencies.

All Cirtec locations are FDA-registered sites certified under ISO 13485, all maintain ISO 14644-1 Class 7 and Class 8 certified clean rooms and all implement quality systems and controls that meet 21 CFR 820 standards.

In addition, we offer regulatory support and experience to help control the time, cost and risk of your device’s clinical and regulatory approval process. Key elements of that process include:

  1. Mapping intended use and indications for use early in the design control process to avoid costly engineering and end-use issues later
  2. Customizing the design of your device to align with regulatory guidance and standards, such as CE Mark, FDA 501(k) and PMA commercial approvals
  3. Performing functional bench testing programs to validate product performance under existing standards
  4. Providing a comprehensive design history file