Has your biological evaluation followed the new ISO 10993-1:2025?
We help your company identify gaps in biological evaluation before biocompatibility questions turn into rework, delays, or submission risk.
- Gap mapping in biological evaluation.
- Review of tests, endpoints, and justifications.
- Analysis of materials, exposure, and risk.
Initial conversation to understand your scenario and outline possible next steps.
Medical device, diagnostics, and life sciences companies trust Sobel to move forward in regulated markets.
This biological evaluation support is for your company if...
Ideal for teams that need to understand whether the current biological evaluation still supports the product under the new ISO 10993-1:2025.
- You already have a biological evaluation
- Tests have been conducted, but there are still uncertainties around the justifications
- There has been a change in material, supplier, or process
- The product is approaching submission, audit, or technical review
Sobel helps your team understand what is well-supported, what is vulnerable, and what may still be missing before the next step.
Tell us about your biological evaluation
Share what stage you’re currently in. We’ll help you identify potential gaps and next steps in light of the new ISO 10993-1:2025.
- Clear next steps
- No commitment required
- Expert review
The initial assessment is a conversation to understand the product’s scenario and outline possible next steps. It does not replace a full technical review of the documentation.
Frequently asked questions
Not always. Tests need to be aligned with endpoints, exposure, materials, intended use, and risk management.
