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We support the legal manufacturer of the device with the planning of the device biological safety assessment and the writing of an objective and compliant report.

When seeking CE marking for a medical device that is intended to contact the body, directly or indirectly, the legal manufacturer must demonstrate that the device is biocompatible, for the specific application. The Biological Safety Assessment Report is the document required to demonstrate the device biocompatibility, regardless of its classification.

Part I of the standard ISO 10993 provides a framework, a systematic approach to plan a biological evaluation (evaluation and testing) within a risk management process. Concisely, the systematic biological evaluation of medical devices involves the determination of the nature of body contact, the precise identification of the materials used in the device and the materials used during the manufacturing of the device, an assessment of the impact of the manufacturing process on the device biological safety characteristics, the evaluation of the existing clinically relevant (biocompatibility) data of these materials and as deemed necessary, if the data is non-existent or insufficient, the biocompatibility testing of the device.

Following the standard (ISO 10993-1) BioTop Medical supports the legal manufacturer of the device with the planning of the device biological safety assessment and the writing of an objective and compliant report.

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