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  • Writer's pictureLouise Hollywood

Device design and development – QMS support

During the design and development process phase of your new medical device, our Quality team can ensure your product meets the highest standards of safety, efficacy, and reliability.

 

Here’s how we can make a difference:

 

  1. Early Quality Integration: Our team believes in the power of early integration of quality frameworks. By embedding quality principles from the start, we help you design devices that are compliant with regulatory standards, reducing risks and ensuring a smoother development process.

 

  1. Comprehensive Quality Management: We provide robust quality management systems (QMS) tailored to your specific needs, ensuring every aspect of your device development is meticulously planned, executed, and monitored.

 

  1. Risk Assessment and Mitigation: Our quality experts conduct thorough risk assessments, identifying potential issues before they arise. This proactive approach helps mitigate risks early, ensuring patient safety and product reliability.

 

  1. Regulatory Compliance: Navigating regulatory requirements can be complex. Our quality team ensures your development process aligns with all relevant standards, helping you avoid costly delays and achieve faster regulatory approvals.

 

  1. Continuous Improvement: We foster a culture of continuous improvement, implementing feedback loops and iterative enhancements throughout the development cycle. This ensures your device remains at the cutting edge of innovation and quality.

 

  1. Documentation and Traceability: Proper documentation is crucial for regulatory submissions and audits. Our team ensures meticulous record-keeping and traceability, providing you with the necessary documentation to support compliance and product validation.

 

  1. Post-Market Support: Our commitment extends beyond development. We provide ongoing support for post-market surveillance, quality audits, and updates, ensuring your device maintains its high standards throughout its lifecycle.

 

Contact us at info@psephos.com to learn more about how our Quality team can support your medical device development journey.

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