Medical Devices

Assurance for animal-derived components of medical devices

Numerous medical devices contain components of animal origin (e.g., pericardium, heart valves, collagen) where the risk of virus and prion contamination needs to be controlled.

Medical devices present several challenges due to the possible incorporation of components of animal origin as well as the inactivation of virus on solid matrices and surfaces. This makes the generation of suitable data for regulatory review particular challenging. ViruSure provides support both via virus/prion clearance studies as well as with risk assessments and literature reviews in compliance with ISO 22442.

ViruSure offers the following services
for users of animal-derived components of medical devices:

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