Concept environment

Sector directory

Medical devices

Assembly, packaging and process context.

Define your needs

Scope

At which production stage is contact made with which surface?

Pre-selection is not site validation.

Environmental class

Classification of airborne particle cleanliness.

Sterility

Scope of the validated process and packaging.

Product performance

Findings obtained with a specific sample, method and conditions.

In this category

Evidence Lab

Evidence dossier structure

Method
Which question is being addressed, using which method.
Sample
Identity of the product and configuration under review.
Condition
The environment and parameters of the test.
Revision
Document version and applicable scope.

No report is currently approved for publication.

Technical dossier consultation

Read a result with its sample.

When method, sample or test conditions change, the scope of results is reassessed.

Review the evidence dossier structure

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