We offer comprehensive contract manufacturing services within ISO7 and ISO8 environment, delivering high-quality production solutions tailored to the stringent demands of the MedTech industry. Our capabilities span PCBA assembly, medical grade plastics manufacturing , precision assembly, box build and testing. This is supported by robust quality management systems and adherence to global regulatory standards.
From pilot builds to full-scale manufacturing, we ensure consistency, traceability, and reliability at every stage. With a focus on efficiency, supply chain optimization, and strict quality control, we help medical device companies accelerate time-to-market while maintaining the highest standards of safety and performance.
Specifically for the Indian Market access, SJML supports MedTech OEMs with CDSCO approvals through manufacturing license applications, test license support, import registrations, and regulatory documentation to enable compliant commercialization in India.
High-speed SMT assembly in controlled ESD environments with in-process inspection, and functional testing for medical electronics.
Medical-grade injection, blow and extrusion moldings, elastomer components, and tooling for regulated medical device platforms.
CNC and VMC machining, sheet metal fabrication, stamping, die casting, MIM, extrusion, laser cutting, and welding for assemblies.
With increasing geopolitical and macroeconomic instability in recent years, companies have recognized the significance of a resilient supply chains and strategic sourcing. We help our customers to stay ahead of disruption and maintain their agility through cutting-edge supply chain, procurement, and logistics processes.
Our supply chain resilience ensures uninterrupted component availability for launches. Dual sourcing, compliant contingency planning, and supplier risk assessment maintain continuity and compliance.
Cost optimization is balanced with strict quality and regulatory frameworks. Strategic sourcing, value engineering, and TCO analysis deliver efficiency without compromising safety, performance, or compliance.
Stringent QA ensures materials meet ISO 13485 and safety standards. SAP-enabled traceability provides full visibility from supplier to finished device, supporting compliance and audits.
Strong supplier relationships ensure consistent quality, reliability, and compliance. Continuous monitoring, audits, and collaboration drive improvement and supply stability.
Our Lean Manufacturing practices, which include “Gemba walks” and Kaizen, ensure the seamless coordination of cross-functional activities. It aligns engineering, quality, regulatory, and supply chain teams to meet stringent compliance and timeline requirements.
Our Design for Excellence (DfX) and New Product Introduction (NPI) readiness focus on optimizing product design for manufacturability, quality, compliance, and cost from the early stages. This ensures a smooth transition from development to production with reduced risks and improved efficiency.
Our review process evaluates component availability, lifecycle status, and compliance requirements. Combined with risk analysis, it helps identify supply chain vulnerabilities, obsolescence risks, and quality concerns, enabling proactive mitigation.
Our robust Process qualification validates that manufacturing processes consistently produce devices meeting defined specifications and regulatory standards. A robust test strategy ensures comprehensive verification of performance, safety, and reliability throughout production.
PFMEA (Process Failure Mode and Effects Analysis) systematically identifies and mitigates potential process risks before production.
Cleanroom Assembly & Plastics Manufacturing
ISO Class 7 & 8 environments for precision assembly and injection molding.
EMC and Reliability Testing High-Precision Electronics Manufacturing
Advanced SMT with SPI, AOI, and X-ray inspection.
Digital Traceability Systems
SAP-integrated MES with end-to-end tracking.
Design optimization, manufacturing scale-up, and regulatory integration enabling a compact, high-accuracy diagnostic platform for global point-of-care deployment.
Precision manufacturing, regulatory enablement, and component localization delivering cost-efficient, audit-ready production of endoscopic device.
From transfer evaluation to production scale-up, the right partner brings disciplined governance and operational stability.
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.
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