One partner, every stage – design, manufacturing, compliance, and lifecycle support. No fragmented vendors, no handoffs, no surprises.
Every India strategy starts somewhere different. Pick yours.
Reducing dependency on one country?
We run the full transfer - technical due diligence, supplier qualification, process validation, and production ramp-up - without disrupting your quality or your output.
Got a prototype or a product brief?
We take it from design to manufacturable, compliant, commercial-ready - engineering, testing, and regulatory built in from day one, not bolted on after.
Margin pressure or component obsolescence eating into your product's life?
Our VAVE and sustaining engineering teams find savings and extend product life - without triggering avoidable regulatory risk.
Looking to enter the Indian medical device market?
Local market entry means CDSCO approval, product localization, and market-specific adaptation. We handle regulatory strategy, product adaptation, and local manufacturing - together, not as separate vendors.
India is no longer just a cost-effective manufacturing destination. It is becoming a strategic second source for global MedTech companies looking for scale, resilience, and market access.
Siemens Healthineers, approved under India's PLI scheme for medical devices, is committing approximately USD 9.6 Mn to manufacture CT and MRI systems in Bengaluru. A USD 200 Mn integrated campus will host R&D, production, an innovation center, and its India headquarters.
Philips Healthcare has invested nearly USD 80 Mn in India in recent years, with a further USD 36 Mn now invested toward expanding its Healthcare Innovation Center (HIC) in Pune.
FUJIFILM India inaugurated endoscopy manufacturing in Jodhpur, India, strengthening the Make in India initiative through a local manufacturing partner and progressive localisation aligned with globally benchmarked Japanese quality standards.
PLI incentives apply to greenfield projects within identified product segments - eligibility varies by category. We assess what applies to your product as part of your Readiness Assessment.
Most companies stitch together a design firm, a factory, and a regulatory consultant - and absorb the risk in between. We don’t make you do that.
SJML provides end-to-end medical device design, regulatory, localization, and contract manufacturing services in India through one integrated program.
Concept-to-prototype development with India-specific DFM/DFA and regulatory-ready documentation from the first design review.
System architecture · Mechanical & electronics engineering · Firmware/software · Prototyping · Design transfer
Explore Design & EngineeringISO 13485 / MDSAP-certified manufacturing - PCBA, medical-grade plastics, precision components, cable assemblies, box build, and cleanroom production - with full traceability.
High-reliability medical PCBA · NPI · Process validation · Cleanroom manufacturing · Pilot to scaled production
Explore Manufacturing CapabilitiesOur QARA team works inside the same program - CDSCO, FDA, and EU MDR/IVDR - so nothing falls through the cracks.
Regulatory strategy · DHF development · Risk management · Global submissions · Audit readiness
Discuss Your Compliance RequirementsSustaining engineering, obsolescence management, VAVE, and regulatory sustenance - protecting your product’s margin and market access for as long as it’s sold.
Engineering change management · Obsolescence monitoring · VAVE · CAPA support · Revalidation
Explore Lifecycle ManagementDesign 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.
No. We can support you through assessment, engineering, compliance, and contract manufacturing without you setting up local infrastructure first. The right commercial structure depends on your product and target market.
IP protection is managed through controlled access, confidentiality agreements, secure documentation handling, defined project governance, and clear contractual safeguards. We follow structured processes to ensure customer designs, technical data, drawings, BOMs, software files, and manufacturing know-how are used only for the agreed project scope.
Quality parity is maintained through documented process transfer, validation, supplier qualification, incoming quality checks, in-process controls, final inspection, and full traceability. Our ISO 13485 and MDSAP-certified systems support regulated manufacturing expectations for global markets.
Yes. Our QARA team can support a multi-market regulatory strategy so that design, sourcing, labeling, documentation, and manufacturing changes are reviewed against the requirements of each target market, rather than being handled in isolation.
A manufacturing transfer generally begins with technical and regulatory due diligence, followed by BOM and supplier assessment, process documentation, tooling and equipment planning, validation, pilot builds, quality approval, and controlled production ramp-up. SJML manages these activities within an integrated engineering, quality, regulatory, and manufacturing program.
No. Eligibility depends on the product category, project type, investment structure, scheme timelines, and applicable government criteria. We can help assess whether your product and manufacturing plan may align with available India-focused incentives as part of the readiness assessment.
Timelines vary based on device complexity, regulatory classification, documentation readiness, supplier readiness, tooling requirements, validation scope, and testing needs. A simple transfer may move faster, while a new device development or regulated manufacturing transfer typically requires a phased plan covering assessment, engineering, validation, regulatory review, pilot build, and scale-up.
Medical device localization can include BOM assessment, local supplier development, alternate-part qualification, tooling, design-for-manufacturing changes, process transfer, validation, regulatory assessment, pilot production, and commercial scale-up. The exact scope depends on the device, existing approvals, target markets, and localization objectives.
Yes. Engagements can begin at concept, prototype refinement, design optimization, verification planning, regulatory readiness, pilot build, or scale-up. The starting point depends on where the product is today and what is needed to make it manufacturable, compliant, and commercially ready.
Dedicated Assembly Line for a Leading Japanese Pioneer in Precision Technology
Tell us where your product is today – we’ll help you understand what it takes to make it compliant, manufacturable, and scalable in India.
