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Clinical Evaluation for Class A Medical Software

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Guest user Created:   May 24, 2021 Last commented:   May 26, 2021

Clinical Evaluation for Class A Medical Software

Is Clinical Evaluation for Class A Medical Software mandatory during submission for certification related to ISO 13485:2016

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić May 26, 2021

In Iso 13485:2016 there is a requirement 4.2.3 Medical device file. It is stated that for each medical device, the organization must establish and maintain files containing documents to demonstrate conformity to the requirement of this ISO standard, but also of applicable regulatory requirements. On the EU market, medical devices must be in compliance with MDR, and there is a requirement that within technical documentation there must be a clinical evaluation.

For more information regarding the clinical evaluation for medical software please see the following guidance: https://ec.europa.eu/docsroom/documents/40323

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May 24, 2021

May 26, 2021