What to Do When the Lab Says, “Substance Unknown”
Chemical characterization is an essential component of the biological safety of medical devices in accordance with ISO 10993. In practice, however, difficulties often arise: labs encounter unknown substances, provide unclear feedback or fail to deliver complete results.
Manufacturers are then faced with the challenge of professionally addressing data gaps without violating regulatory requirements.
In this seminar, learn about the typical pitfalls of chemical characterization, how to specifically improve communication with testing laboratories and how to conduct a sound toxicological assessment even with incomplete results.
The focus is on a pragmatic, risk-based approach in accordance with ISO 10993-18 and 10993-17.
- Content
- Chemical characterization according to ISO 10993-18: Requirements and limitations
- Typical laboratory reports and their significance (“unknowns,” LOD, LOQ, non-targeted screening)
- Communication with laboratories: What can I request—and what can’t I?
- Toxicological interpretation of incomplete data (ISO 10993-17:2023)
- Strategies for risk-based management of unidentified substances
- Practical examples and decision-making aids for critical scenarios
- Tips for documentation and justifying decisions to Notified Bodies
- Your Benefits
- You’ll learn about the most common challenges in chemical characterization and how to address them
- You’ll be better able to evaluate lab reports and request additional information in a targeted manner
- You’ll learn how to proceed with meaningful toxicological analysis even when data is limited
- You’ll receive concrete examples of formulations and practical solutions
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Medical device manufacturers
- Professionals responsible for biological evaluation and toxicology
- Technical documentation specialists
- Regulatory affairs and quality management professionals
- R&D staff
- Service providers, laboratories, and consultants
