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:

Process Validation Studies
Medical Devices

Virus Clearance Studies

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Prion Clearance Studies

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Pathogen Safety Testing

Sterility + Mycoplasma Testing

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Molecular Tests (e.g. qPCR)

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Pathogen Safety Characterization

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Consultancy

Consultancy + Risk Assessments

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Others

Research + Development

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Disinfectants

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Let's Talk About Your Medical Devices

Tell us about your inquiry and we'll be in touch.