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As regulations for medical devices, combination devices and in vitro diagnostics change and your quality systems are updated, gaps in existing technical documentation can emerge and raise compliance issues for current developments or on market products.

Our quality and regulatory experts – consisting of mechanical, electrical, software and biological science experts - can assess your product documentation, identify gaps and work alongside you to define a remediation plan to create required records for compliance to:

  • ISO 13485:2016

  • 21CFR 820

  • Medical Device Single Audit Programme (MDSAP)

  • Medical Device Regulations (MDR)

  • In Vitro Diagnostics Regulations (IVDR)

  • IEC 62304

  • ISO 14971

  • IEC 60601

CDP can also offer remediation and guidance for medicinal products, veterinary products, consumer goods and beauty and consumer healthcare products.

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