Materials don’t stay still. A resin supplier reformulates. A coating moves plants. An additive package changes to meet a new regulation. Yet the drawing may remain exactly the same.
For MedTech manufacturers, every material change can trigger a chain of questions across biocompatibility, toxicology, testing, compliance, and regulatory submissions.
The challenge goes beyond testing
Regulatory expectations continue to evolve:
- ISO 10993-17:2023 changes how constituents are assessed.
- ISO 18562:2024 brings updated expectations for material emissions assessment.
- EU MDR remediation continues to reopen legacy files.
- PFAS restrictions add to the existing RoHS, REACH, and SCIP compliance burden.
The real complexity often sits between the tests-choosing the right extraction approach, understanding what the compound list actually means, assessing toxicological impact, and determining whether a material substitution affects biocompatibility or V&V.
Engineering Intelligence that connects the dots
LTTS brings together materials engineering, analytical testing, toxicology, and regulatory expertise to turn material changes into submission-ready decisions.
We help you:
- Scope the right testing based on the material, application, and regulatory requirement
- Execute testing under accredited laboratory conditions
- Interpret analytical results through a toxicological lens
- Assess the impact of material and supplier changes
- Identify potential risks to biocompatibility and V&V
- Build the evidence package needed for regulatory submissions
Download the brochure to know more.