Brochure
Medical Devices

Innovative Solutions for Sterile Medical Devices

Use of non-standard terminal sterilization modalities.

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In this document:

Non-standard sterilization modalities.
Development and validation requirements.
Regulatory assessment of change of sterilization modality.

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Informatie en media

EU MDR – Post Market Clinical Follow-Up

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Annex XVI - Devices Without an Intended Medical Purpose

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Using Standards to Demonstrate Conformity

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Unlocking the Potential of Consumer Wearables in Healthcare

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Medical Device Lifetime - Assisting manufacturers

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Symbols & Details Required for Medical Devices & IVDs

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