PFAS are widely used in medical devices and diagnostics for their lubricity, chemical resistance, thermal stability, and biocompatibility.
Syrma Johari MedTech supports this through end-to-end PFAS compliance, including assessment, material mapping, risk mitigation, and regulatory documentation aligned with global frameworks such as TSCA, REACH, and CEPA. With integrated engineering and regulatory expertise, SJML helps OEMs manage PFAS risks while ensuring compliance and sustained market access.
PFAS mapping in concepts, BOMs, and CAD data; design reviews for risk, alternatives, and essential-use justification; prototyping and design-change impact assessment.
PFAS screening for materials, coatings, packaging, reagents, and components; extractables and leachable studies; testing aligned to device-specific requirements.
From portfolio review to reporting and transition strategy
Collection and normalization of BOMs, material declarations, and historical documentation.
Quality review of available records before analysis begins.
Initial screening, expert review, and mapping to applicable global frameworks.
Targeted supplier engagement for missing declarations, clarifications, and evidence gathering.
Analytical testing for unresolved SKUs, components, coatings, packaging, or process-related residues.
Preparation of submission-ready data packs, templates, declarations, and evidence files.
Identification of PFAS-free or lower-risk alternatives, impact assessment, and transition planning.
Partner with us to discuss the impact on sourcing, design, submissions, and global continuity.
PFAS are synthetic fluorinated chemicals, but regulatory definitions differ by jurisdiction. Some frameworks cover hundreds of substances, while others apply class-based definitions covering thousands. That is why multi-market compliance requires more than a single material declaration.
In most frameworks, yes. Materials such as PTFE, PVDF, FEP, and related fluoropolymers generally fall within PFAS definitions, although reporting treatment may vary by jurisdiction and use case.
Yes. Standard supplier documents may not capture low-level PFAS content, process residues, or trace contamination. That is why supplier follow-up and testing are often necessary.
That depends on your target markets, product category, manufacturing footprint, and material profile. Applicable frameworks may include TSCA, TRI, REACH, SCIP, CEPA, RoHS, Prop 65, and others.
Depending on the application, testing may include LC-MS/MS, total organic fluorine screening, precursor analysis, and extractables/leachables studies.
In many cases, yes. Material changes may trigger design verification, biocompatibility review, sterilization validation, and regulatory documentation updates.
Potentially, but only with strong technical and regulatory justification. Manufacturers may need to demonstrate necessity, lack of viable alternatives, and an active transition strategy.
Yes. SJML can support ongoing monitoring, supplier re-verification, new product screening, regulatory updates, and long-term PFAS reduction planning.
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