TiCOME brings together manufacturing, scientific consulting, and engineering design under one trusted brand.
Reduce uncertainty, close regulatory gaps, and move forward with confidence through expert ISO 10993 consultancy.
.png)
From gap assessments to complete regulatory packages — every stage of biological safety evaluation.
D&D support for New Product Development (NPD) and Life Cycle Management (LCM) — including experiment design (DOE) and all documentation.
Gap assessments and biological evaluations per ISO 10993. Full creation of BEP, BER, CEP, and CER documents for EU MDR and FDA.
Safety and risk assessments per ISO 10993-17 — the cornerstone of any medical device submission. Thorough, regulator-ready TRA documentation.
D&D support for New Product Development (NPD) and Life Cycle Management (LCM) — including experiment design (DOE) and all documentation.
Led by Dr. Valjavanthi Ramesh, our Scientific Services division provides comprehensive biocompatibility and regulatory consulting support for medical device manufacturers worldwide.
We create regulator-ready documentation aligned with ISO 10993, EU MDR, and FDA frameworks.
We go beyond surface-level advice — our consulting approach is built on international experience, strategy, and execution
"The quality of the MMO-coated titanium anodes we received exceeded our expectations. The durability in high-salinity environments has significantly reduced our maintenance downtime. A reliable partner for industrial-grade components." Marcus Thorne, Operations Director at AquaFlow Systems
"Their team provided a comprehensive ISO 10993 biological evaluation that was instrumental in our FDA submission. The toxicological risk assessment was detailed, precise, and delivered ahead of schedule. Truly experts in med-tech compliance." Dr. Elena Rodriguez, Operations Director at AquaFlow Systems
"TiCOME's electrode assemblies have consistently outperformed our benchmarks. Their technical support team is highly responsive and deeply knowledgeable. A long-term partner we truly rely on." Rajesh Kumar, Head of Procurement, Murugappa Group
"The biocompatibility evaluation delivered by TiCOME was thorough, scientifically rigorous, and exceeded CE compliance requirements. They saved us months of regulatory back-and-forth." Sophie Laurent, R&D Director, MedDevice Europe GmbH
"The UF membranes supplied by TiCOME have dramatically improved our filtration efficiency. Consistent quality across every batch — exactly what large-scale operations need." Anand Nair, Plant Manager, Hollowbrane Membrane Technologies
"The quality of the MMO-coated titanium anodes we received exceeded our expectations. The durability in high-salinity environments has significantly reduced our maintenance downtime. A reliable partner for industrial-grade components." Marcus Thorne, Operations Director at AquaFlow Systems
"Their team provided a comprehensive ISO 10993 biological evaluation that was instrumental in our FDA submission. The toxicological risk assessment was detailed, precise, and delivered ahead of schedule. Truly experts in med-tech compliance." Dr. Elena Rodriguez, Operations Director at AquaFlow Systems
"TiCOME's electrode assemblies have consistently outperformed our benchmarks. Their technical support team is highly responsive and deeply knowledgeable. A long-term partner we truly rely on." Rajesh Kumar, Head of Procurement, Murugappa Group
"The biocompatibility evaluation delivered by TiCOME was thorough, scientifically rigorous, and exceeded CE compliance requirements. They saved us months of regulatory back-and-forth." Sophie Laurent, R&D Director, MedDevice Europe GmbH
"The UF membranes supplied by TiCOME have dramatically improved our filtration efficiency. Consistent quality across every batch — exactly what large-scale operations need." Anand Nair, Plant Manager, Hollowbrane Membrane Technologies
Whether you need manufacturing, scientific consulting, or engineering support our team is here.