Medical device contract manufacturing services involve outsourcing regulated production to a specialized manufacturer operating within ISO 13485–aligned quality systems. Services typically include mechanical manufacturing, PCB assembly, validation, packaging, labeling, and supply chain coordination.

Syrma Johari MedTech operates exclusively in regulated MedTech manufacturing. Our design-aligned transfer processes, vertically integrated metal, plastics, and PCBA capabilities, and global regulatory compliance frameworks support controlled production continuity.

We support Class I, II, and III medical devices across diagnostics, patient monitoring, drug delivery, critical care, rehabilitation, medical aesthetics, and surgical platforms.

Yes. Manufacturing operates within ISO 13485 and ISO 27001 certified systems and complies with FDA 21 CFR Part 820, EU MDR/IVDR, MDSAP, Health Canada, CDSCO, and other applicable regulatory frameworks. Full traceability and risk-based documentation are maintained.

Yes. Our facilities include ISO Class 7 and Class 8 cleanrooms, controlled ESD environments, optics assembly rooms, and validated sterile and non-sterile packaging capabilities.

Yes. Structured design transfer includes DFM reviews, NPI planning, DMR finalization, and IQ/OQ/PQ validation to ensure stable production readiness.

Geo-diversified operations across India, the U.S., and Europe support trade flexibility and production continuity. Capabilities include supplier qualification, SAP-enabled inventory tracking, predictive risk monitoring, and obsolescence management.

Intellectual property is safeguarded through structured MSAs and NDAs, ISO 27001–aligned information security controls, access governance systems, and controlled digital and physical environments.