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Quality & Regulatory
NextPhase Medical Devices

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Medical Device Quality & Regulatory

Looking for a medical device manufacturer with a robust and proven quality management control process?

At NextPhase Medical Devices we’re committed to the highest standard of quality.

We continuously work to ensure that we meet all quality and regulatory requirements throughout your entire product life-cycle. Our quality and regulatory critical management systems help to ensure the success throughout each stage of the process of all Class I, II, and III medical devices that we design, develop, manufacture, and assemble.

We assist with agency approval process using certified third-party suppliers to demonstrate with evidence that there is reasonable assurance that the device or device system is safe and effective for its intended uses.

We’re knowledgeable and can assist with the U.S. Food and Drug Administration’s requirements according to Center for Devices and Radiological Health (CDRH) 510(k) Premarket Notification and Premarket Approval (PMA), De Novo and Humanitarian Device Exemption, Recall and Adverse Event Reporting.

As part of quality and regulatory, we understand the importance of having validation and verification processes in place early in the design stage as the required specifications are developed for your medical device. This streamlines the overall manufacturing and approval process, thus saving time and money.

Our quality & regulatory systems

  • Robust ISO 13485 certified quality management system
  • QMS spans entire product lifecycle from design to manufacturing
  • Focus on requirements as defined by the customer
  • Best-in-class LEAN manufacturing practices to detect abnormalities early
  • FDA establishment registration and device listing
  • Quality policy and objectives are clearly defined and deployed at all levels
  • Deep understanding of compliance requirements to support our customers innovation strategies
  • Extensive experience generating and executing verification and validation protocols
 

Do you have a question about our quality & regulatory systems?