Management of the Device Biological Safety Assessment
BIORIUS supports the biocompatibility of Medical Devices 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, the manufacturer must demonstrate that the device is biocompatible for its specific application.
The Biological Safety Assessment Report is the required document to demonstrate it, regardless of the device classification.
The strategy proposed by BIORIUS is divided in three steps and follows Part I of the ISO 10993 standard:
- Biological Safety Evaluation Plan (BSEP)
- Testing & Toxicological Risk Assessment (TRA)
- Biological Safety Evaluation Report (BSER)
Our team of experts can support you to provide all or a subset of this required documentation within a reasonable time frame.
We can also have the testing performed for you.
Contact us to learn more and receive a quotation!