The Biological Safety of a device must be demonstrated not only when placing it on the market, but throughout its complete lifecycle.​

Biological Safety & Biocompatibility

The Biological Safety of medical devices needs to be evaluated, to protect human subjects from potential biological risks arising from the use of the device.


Biocompatibility of medical devices is a critical and evolving subject. As long as a device has any direct or indirect tissue contact, European authorities as well as the FDA will need biocompatibility information in the submission.


The principle for collecting and evaluating the Biological Safety of a medical device is outlined in ISO 10993-1 and follows the risk-based approach described in ISO 14971. This process requires the identification of risks related to raw materials, packaging, manufacturing, degradation, and a series of other aspects.

​Key Challenges Faced by Medical Device Manufacturers

ISO 10993-1-compliant Biological Safety Evaluation

Safety issues regarding biocompatibility during the development, production and use of medical devices are to be detected and managed throughout the process of Biological Risk Assessment. Such assessment must be conducted by expert assessors who have the necessary knowledge and experience. ​

Defining the Biological Safety test plan

Testing strategies should be carefully constructed. In view of reducing animal life costs, some testing can sometimes be waivered. However, when endpoints are waivered, these should be adequately justified. Furthermore, Notified Bodies and the FDA are placing more and more importance on testing methodologies and conditions.

Toxicological analysis of test results

Once testing has been completed and in order to draw a conclusion regarding the Biological Safety of the device, it is necessary to interpret the test results provided by the test laboratory. For the interpretation of some tests, a Toxicological Risk Assessment must be conducted.

How Medidee Supports ​your Biocompatibility Activities

Medidee’s committed team of experts supports you with a complete range of services, with the goal of defining the most adequate testing strategy and preparing rationales to waive the end-point tests that are unnecessary.

File Review

Review of all pertinent documentation: collection and compilation


Preparation of an initial Biological Risk Assessment (BRA) compliant with ISO 10993-1

Testing Plan

Preparation of test plans for the chemical/physical characterization and biological endpoints

Testing Labs

Support on communication with test labs

compliance - quality

Evaluation of the test results, including calculation of Allowable Limits as part of the Toxicological Risk Assessment (TRA)

Technical Documentation

Updates of previous Biological Risk Assessments (e.g., following a manufacturing change)

Biocompatibility of medical devices is a critical and evolving subject. As long as a device has any direct or indirect tissue contact, FDA and other authorities will need biocompatibility information in the submission. During this on-demand webinar, you will be guided through the Biocompatibility Workflow by our expert Dr Adrien Marchand.

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A Knowledgeable Team you can Rely on

To prepare a comprehensive standard-compliant evaluation of the Biological Safety of medical devices, an efficient and customized approach is necessary.


Medidee’s team offers the expertise, resources, and unique experience gathered from frequent interactions with Notified Bodies and the FDA, and from supporting hundreds of Medical Device manufacturers.


By working with Medidee, you will find the right strategy for the biological testing of your device, taking into consideration the relevant regulatory framework, as well as your overall business objectives.

Testing Strategy

Contact Medidee to discuss your needs