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Pune, India
402, Tower 2, World Trade Center, Kharadi, Pune – 411014, India.
INDIA: 1800-102-8684
USA: +1-918-918-3277
EU: +49-176-23608589
Syrma Johari MedTech operates ISO 13485 and US FDA–certified facilities, following Good Manufacturing Practices (GMP) across all manufacturing operations. Our Quality Management System (QMS) is structured in accordance with ISO 13485, MDSAP, FDA Quality System Regulation (21 CFR Part 820), EU MDR, UKMHRA, Japan’s MHLW, Health Canada, and India’s CDSCO, along with other applicable international regulations. This integrated compliance framework ensures consistent product quality and reliability across every market we serve.
Our quality control framework includes rigorous supplier assessment and qualification, raw material quality inspection, in-line inspections during production, and final product validation. Continuous improvement is driven through KAIZEN initiatives, Corrective and Preventive Actions (CAPA), Engineering Change Requests, and statistical reviews. We maintain Device History Record (DHR) for end-to-end traceability across production batches.
Yes. We offer complete customization of devices to meet specific design requirements. Our design and engineering teams collaborate closely with clients during the development phase to ensure every technical specification is met. Prototype validation is conducted before mass production to ensure optimal performance and alignment with customer expectations.
We operate 16 global manufacturing facilities with scalable infrastructure and a diversified supplier network. Our 34 high-speed SMT lines support an annual PCB assembly capacity of over 5 million units. This robust setup enables seamless scale-up from prototype to high-volume production while maintaining consistent quality and stringent regulatory compliance.
We adopt a structured approach to ensure our products and processes remain at the forefront of technology. Sustenance engineering is performed through continuous post-market surveillance and feedback-based product enhancements. Our dedicated R&D team monitors emerging trends and collaborates with strategic partners to drive innovation. Manufacturing processes are updated in real time as designs evolve, ensuring alignment with the latest technologies. We also place strong emphasis on ergonomic, user-centric device design to meet evolving customer and market needs.
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