15,000 fluorinated chemicals. One restriction clock. Devices patients cannot go without.
- Find what you actually own with BOM scrubs three to four tiers deep, tier 2 and tier 3 CoC chasing, and SCIP plus Article 33 SVHC disclosures
- Prove it, don't assume it through CAS level composition mapping and targeted PFAS analytics via TÜV SÜD partnered labs
- Avoid regrettable substitutions by screening alternatives across biocompatibility, dielectric, sterilization and tribology before you commit
- Re-validate to NB standard, not consultant standard with ISO 14971, ISO 10993, sterilization and EMI/EMC deliverables built for submission
- Keep the certificate live and the launch clock running with significant versus non significant determination under MDR Art. 120 and IVDR Art. 110
- Get ahead of your supply chain with tier 3 supplier orchestration, dual sourcing and obsolescence planning before vendors de risk first
- Backed by proof at OEM scale: 450+ medical product developments, 290+ patents, 15 MedTech R&D labs, and 10 percent per unit cost reduction on a live redesign
Standards native by practice: ISO 13485, IEC 62304, ISO 14971, IEC 60601-1, MDR and FDA 510(k), written daily rather than consulted on from the outside.
Download the Brochure to see how LTTS turns a PFAS restriction deadline into a controlled, certifiable transition plan.
Download Brochure