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Do you need to create or update technical documentation for an ongoing product development or legacy product?
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:
Medical Device Single Audit Programme (MDSAP)
Medical Device Regulations (MDR)
In Vitro Diagnostics Regulations (IVDR)
CDP can also offer remediation and guidance for medicinal products, veterinary products, consumer goods and beauty and consumer healthcare products.
Other relevant pages:
Regulatory review >
Design History File / Technical File remediation >
Quality Management Systems >