Whitepaper
Medical Devices

Innovative Solutions for Sterile Medical Devices

How the use of a non-standard sterilization technology in the manufacture of medical devices has both benefits and risks that need to be considered.

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Regulators are responding to public concerns about safety and environment

This paper offers guidance on the use of non-standard terminal sterilization modalities, including:

Emerging factors driving innovation.
Development and validation requirements.
Regulatory assessment of change of sterilization modality.
BSI Accreditations and Designations.

Insights & Media

Learn from global experts in healthcare standards

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