A Preliminary Design Review (PDR) enables you to design with confidence and streamline compliance for your medical devices

Intertek’s Preliminary Design Review (PDR) for Medical Devices offers manufacturers a proactive approach to ensuring compliance with global standards. By engaging with our experts early in the product development cycle, you can establish an efficient compliance program that reduces risks and accelerates your path to certification. Our comprehensive review process evaluates your design against critical regulatory requirements, including IEC 60601-1, FDA guidelines, and more, helping you build confidence in compliance from the start.

With Intertek’s design for compliance expertise, potential issues are identified and resolved before costly testing phases begin. This ensures your product development stays on schedule, allowing for faster time to market. By streamlining the compliance process, you can allocate resources more effectively, avoid delays, and position your product for greater revenue potential in competitive markets.

Our Preliminary Design Review services are tailored to the unique challenges of medical devices, including complex component integrations and evolving regulatory landscapes. Whether developing innovative imaging equipment or implantable devices, Intertek empowers you to design with confidence and achieve compliance efficiently.

Trust Intertek to help you deliver safer, more effective medical devices to global markets with speed, efficiency, and reliability. Begin your journey with a Preliminary Design Review today.

 

Intertek’s Preliminary Design Review (PDR) service for Medical Devices can result in significant time and cost savings when launching your device – where you want, when you want, and well before your competition.

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** The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.