The ISO 10993-1:2025 update can affect how your biological evaluation, materials information, exposure rationale and testing strategy are documented for medical device submissions.
Sobel helps medical device companies review existing biological evaluation documentation, identify update gaps and define the next technical-regulatory step based on the device, body contact, materials, evidence and target market.
Your request will be reviewed by a technical-regulatory specialist, and we will follow up with the next steps.
Not sure what the ISO 10993-1:2025 update means for your device? Start with an update assessment · Read the FAQ · Request specialist support
Trusted technical-regulatory support for medical device companies
For manufacturers, regulatory teams and medical device companies that need to understand whether existing BEP/BER files, test reports and rationales are aligned with the updated ISO 10993-1 approach.
You do not need to know exactly what your biological evaluation needs before contacting us. The initial assessment is designed to help clarify the next technical-regulatory step.
A file that was acceptable under a previous approach may still need review when standards, expectations or documentation logic change — especially before submission, audit or regulatory response.
Sobel reviews your current biological evaluation documentation, available evidence and update scenario to help identify what may need to be revised before submission, audit, renewal or regulatory response.
A structured review of your existing biological evaluation documentation and supporting evidence.
A clearer view of what your update path may require.
Assessment focused on existing files, update gaps and the next technical-regulatory step.
You do not need to know exactly what needs to change — that is what the ISO 10993-1:2025 update assessment is designed to clarify.
Tell us about your device, body contact, target market and current ISO 10993 documentation.
Our technical-regulatory team reviews your current files, available data, documentation logic and potential update gaps.
We evaluate whether existing ISO 10993 data, reports and rationale may still support the updated strategy.
We help clarify whether your case may require stronger rationale, documentation updates, additional review or regulatory response support.
Your team gains a clearer view of what should be updated before the next regulatory step.
ISO 10993-1:2025 updates require qualified interpretation. Sobel brings specialized support to review files, gaps and technical rationale with regulatory perspective.
We review ISO 10993 documentation in relation to the device, materials, body contact, intended use and target market.
Our review is focused on whether the biological evaluation file can support the next regulatory step under the updated approach.
We help your team understand whether to move forward, strengthen the rationale, revise documentation or consider additional evidence.
“We experienced a very friendly, target-oriented service with fast solutions, and we look forward to continuing our work with Sobel.”Andreas KohlAndraTec
Yes. Many companies do not know whether the update affects their current files, rationale or evidence strategy. The initial assessment helps identify the most appropriate next step.
Not always. The need for additional testing depends on the device, materials, body contact, intended use, available evidence, documentation quality and regulatory pathway.
In many cases, existing data may still be useful, but it should be reviewed in relation to the specific device, contact type, materials, documentation quality, technical rationale and target market.
Existing documents can be valuable, but they should be assessed for relevance, completeness and alignment with the updated biological evaluation approach.
Sobel provides technical-regulatory consulting support. Our role is to help companies assess update needs, review data, identify gaps and define the next regulatory step.
Device type, body contact, target market, current stage, available ISO 10993 data or reports, current BEP/BER if available, and your main update question.
Yes. Your technical information is handled confidentially and used only to understand your request and provide relevant support.
A technical-regulatory specialist will review your update request and follow up with the most appropriate next steps.
Share your current documentation, available evidence and main question. Sobel’s technical-regulatory team will review your scenario and help identify the most appropriate next step.
Start my assessment →Confidential · Specialist review · Update-focused
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