Devices Composed of Substances: Integrating Scientific Rationale and Testing for Biological and Toxicological Safety Assessment
Speaker: Hicham Saaid, Medical device consultant, Eurofins Medical Device Services – Benelux
Date: 25 November 2026
Time: 15:00 - 15:45 CET
Language: English
Devices composed of substances present unique challenges for biological and toxicological safety assessment. Demonstrating safety often requires combining information from multiple sources, including chemical characterisation, biological evaluation, toxicological risk assessment, supplier information, and regulatory considerations.
In some cases, traditional biocompatibility testing may not be feasible or scientifically appropriate, requiring alternative strategies such as literature-based justifications and scientific rationales. Even when testing can be performed, generating representative extracts and establishing suitable test conditions can be challenging.
In addition, information related to raw materials, manufacturing processes, and packaging materials, particularly when provided by external suppliers, can play a critical role in supporting safety conclusions. This webinar will explore practical approaches to addressing these challenges while supporting a scientifically sound and compliant safety assessment.
In this webinar, you will learn:
- How to integrate scientific rationale and testing into biological and toxicological safety assessments for devices composed of substances
- Key regulatory considerations for biological safety assessment
- The role of chemical characterisation and toxicological risk assessment
- How manufacturing, supplier, and packaging information can support safety assessments
- When testing may not be feasible and how to leverage literature data and scientific rationales
- Common challenges associated with extract generation and biological testing
Who Should Join?
- Medical device manufacturers developing devices composed of substances
- Research & development teams
- Regulatory affairs professionals
- Toxicologists and biological safety specialists
- Quality and risk management professionals
- Clinical and medical affairs teams
- Professionals involved in biological evaluation and technical documentation
In Summary:
This webinar explores practical approaches to the biological and toxicological safety assessment of devices composed of substances, covering chemical characterisation, toxicological risk assessment, regulatory expectations, and the use of scientific rationale and supporting data to demonstrate safety.