Medical Devices Electronics Manufacturing in India
Karkhana is a medical electronics manufacturing company in India, providing electronics manufacturing for medical device companies under an ISO 13485-certified quality management system. From patient monitoring and diagnostic equipment to infusion pumps and ventilators, we handle component sourcing, PCB assembly, inspection, testing and system integration with the documentation required for regulated medical devices.
AOI
Hole Lines
Medical Electronics Manufacturing Capabilities
Medical electronics manufacturing is judged on evidence as much as on function. Every stage of our medical electronics manufacturing process follows a documented workflow, with records maintained so a finished device can be traced through its build.
Controlled PCB Sourcing
Bare PCBs are sourced to your specification through qualified fabrication partners, with material and stack-up details recorded so repeat builds remain identical to the validated original.
Component Sourcing & BOM Control
Component procurement runs through approved supplier networks with BOM control, so components used in a medical electronics assembly match your specified design without undocumented substitutions.
SMT & Through-Hole Assembly
Automated SMT lines support medical PCB assembly for dense sensing and control boards, with through-hole assembly for connectors and components requiring mechanical strength.
Prototype & Design Validation Builds
Prototype and design validation builds support the verification work that has to happen before a device design can be frozen, helping establish a controlled path from prototype to production.
Low-Volume Clinical Builds
Low-volume builds suit clinical evaluation units, pilot batches and early market release, produced on the same documented process as later production.
AOI & X-Ray Inspection
Automated optical inspection verifies every joint and X-ray inspection reaches concealed joints on BGA and bottom-terminated packages, with inspection results documented for traceability.
Electrical & Functional Testing
Electrical testing and functional validation are run to the test plan agreed with you, and results are documented against each production batch for consistent medical electronics quality and traceability.
Conformal Coating
Conformal coating protects medical electronics assemblies from moisture, cleaning agents and the handling conditions equipment can encounter in clinical environments.
Scalable Device Production
Production scales without changing the underlying manufacturing process, so the medical device you validated follows the same controlled process as you move into commercial production.
Why Medical Device Companies Choose Karkhana
For a medical device, the manufacturing partner becomes part of the quality record. Karkhana brings a certified quality system together with engineering, sourcing and medical electronics assembly in one facility.
ISO 13485 Certified
Our quality management system is certified to ISO 13485, the international standard for medical device manufacturing, alongside ISO 9001.
Documented, Repeatable Process
Work instructions, process controls and change control make each build repeatable and support consistent medical electronics manufacturing across production runs.
Controlled Component Supply
Approved supplier networks and BOM discipline keep component sourcing under control, helping ensure the components used in each medical electronics assembly match the specified design.
Validation Builds to Production
Design validation builds, clinical batches and commercial production run through the same facility and the same documented manufacturing process.
Manufacturability Review
Manufacturability review before a medical device build helps identify production issues early and avoid design changes that become difficult to make once the device has gone through verification.
Full Batch Traceability
Batch records, inspection data and production traceability, retained and available for audit, supporting traceability throughout the medical device manufacturing process.
Harness & Enclosure Assembly
Harness assembly, mechanical build and enclosure integration are carried out under the same controlled process as the boards themselves.
Dedicated Programme Team
One team coordinates engineering, procurement, production and quality, giving your regulatory and operations staff a single point of contact throughout the medical device manufacturing process.
Looking for a Medical Electronics Manufacturer in India?
Karkhana manufactures medical electronics under ISO 13485, with integrated sourcing, assembly, inspection, testing and documentation.
Medical Device Contract Manufacturing
Karkhana provides medical electronics contract manufacturing for medical device companies that need electronics production within a certified quality system. We coordinate board procurement, controlled component sourcing, PCB assembly, inspection, testing and system integration through a single documented workflow.
Consolidating the build with one manufacturing partner keeps the quality record in one place, providing a streamlined path from prototype and validation builds to production while supporting the documentation requirements of regulated medical devices.
Medical Products We Manufacture
Our medical electronics manufacturing capabilities spans diagnostic, monitoring, therapy and critical care equipment, along with the sub-assemblies that support these products.
Diagnostic Imaging
Electronics for diagnostic imaging systems, supporting precise image capture, processing and control.
Patient Monitoring Systems
Reliable electronics for continuous monitoring, sensing and display of critical patient parameters.
Infusion Pumps
Precision electronics for controlled fluid delivery, monitoring and pump operation.
Infant Incubators
Control and monitoring electronics for maintaining stable temperature and environmental conditions.
Ventilators & Analysers
Electronics for respiratory support, measurement, monitoring and analytical medical equipment.
Medical Sub-Assemblies
PCBAs, control boards and electronic sub-assemblies for integration into medical devices.
From Medical PCBAs to Complete Assemblies
Medical equipment ships as an assembly, not a board. Karkhana provides medical PCB assembly and complete medical electronics assembly services, including PCB assembly, box build assembly, wire harness manufacturing, mechanical assembly, functional testing, component sourcing, system integration and final product assembly, so a controller or pump can leave the facility as a complete build.
Working with one manufacturing partner helps simplify vendor coordination and provides a more streamlined path from prototype to finished product, with sourcing, assembly, testing and integration managed through a controlled manufacturing process.
Built for diverse product demands
We work closely with OEMs across five industries, aligning on requirements early to keep production moving with intent.
Automotive
Powering innovation in modern vehicles
Industrial
Dependable electronics for demanding industrial environments
Consumer
Delivering high-quality components for reliable and innovative devices
Energy
Supporting the shift to smarter, cleaner power
Medical Devices
Delivering precision for life-saving technologies
Backed by Global Standards
Quality in medical electronics manufacturing is a documentation discipline as much as a production one. Every stage at Karkhana — incoming component verification, assembly, inspection, testing — generates records tied to the batch it came from.
Our quality management system is certified to ISO 13485 for medical devices, alongside ISO 9001, ISO 14001 and IATF 16949:2016, giving medical customers documented processes and audit-ready production records.
Industry Certifications
Medical Devices
Automotive
Let’s Build Your Medical Device
Move your medical device from validation builds into production with sourcing, assembly, testing and documentation handled under a certified quality system.
Frequently Asked Questions
Yes. Karkhana holds ISO 13485, the international quality management standard for medical device manufacturing, alongside ISO 9001, ISO 14001 and IATF 16949:2016.
Karkhana manufactures electronics for diagnostic imaging equipment, patient monitoring systems, infusion pumps, infant incubators, ventilators and analysers, along with medical sub-assemblies used in larger medical devices.
Yes. Karkhana provides medical device electronics manufacturing in India at our Bangalore facility, covering component sourcing, SMT and through-hole PCB assembly, inspection, testing, wire harness manufacturing and final integration.
Yes. We support prototype and design validation builds, clinical and pilot batches, and commercial production volumes through the same documented manufacturing process, providing a controlled path from validation to production.
Component procurement runs through approved supplier networks with BOM control. Substitutions are controlled through an established process so components used in medical electronics assemblies match the specified design.
Builds are traceable at batch level. Component verification, assembly records, inspection results and test data are documented and retained, so a unit in the field can be traced back through its production history.
Automated optical inspection, X-ray inspection for hidden joints, electrical testing and functional validation, applied per the test plan agreed with you and recorded against each batch.
Gerber files, a BOM, assembly drawings, mechanical details, your inspection and test requirements, any documentation or traceability requirements from your quality system, expected volumes and a timeline.
No. Karkhana manufactures to your design and quality requirements under its ISO 13485 certified system and supplies the production records that support your device documentation. Regulatory clearance, device registration and the design history file remain the responsibility of the legal manufacturer — that is, you.
Looking for a Medical Electronics Manufacturing Partner?
Manufacture your medical device electronics under an ISO 13485 certified system, with sourcing, assembly, testing and documentation from one partner.
Capabilities
Bangalore Office
4th Floor, PB Soft Tech, Hosur Rd, Electronic City Phase II, Konappana Agrahara, Bengaluru, Karnataka 560100
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