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Concept, Design, Prototype & Validation

Taking leverage of its proven Product Engineering strength, HCL offers solutions to medical device manufacturers at each and every stage of the product lifecycle. HCL partners with the Medical Device manufacturers right from the requirements definition to the end, or in any specific stage of the product lifecycle.

HCL is one of the few vendors in the world providing end-to-end services in this area there by ensuring reduced time to markets for customers.

HCL has exhaustive experience of working with top medical device manufacturers on some of the most complicated and sophisticated medical devices including Blood Glucose Meter, Sterilization System, Disinfection System, Drug Delivery System, Nerve stimulator, Dialysis Equipment, Infusion System, Blood chemistry Analyzer, Patient Monitoring System, Ablation and Sensing Unit, Diabetes Management Software, Implantable Drug Delivery system, Computer Radiography System, X-Ray cartridge readers, X-Ray Systems, ICD, Breast Biopsy System, Orthopedic implants, Cardiovascular implants Laparoscopic Device and many more.

Practice Highlights

  • Proven systems and processes that assure cost benefits

  • Rich portfolio of reusable, modular frameworks ensures shorter time-to-market

  • 24 X 7 support on our development services

  • Investments in dedicated labs and resources for medical devices customers

  • FDA registered design house for end-to end concurrent design and development of medical devices

  • Extensive work experience across Class I, II and III medical devices and equipment

  • World class processes like Six Sigma, CMMi Level 5, SEI CMM Level 5, PCMM Level 5, ISO 9000, MDD ISO-13485 and BS 7799

  • Flexible Business models like Global Risk Reward Program and Output-based Pricing

  • Strategic Partnerships Alliances with GVK Bio (CRO), Human Factors International and Celestica

  • Focused IPs Frameworks like MQMS(Medical Quality Management System) based on ISO 13485 and ISO 14971, FDA QSR, Client Quality Systems

  • Dedicated CoE with strong team of product engineers specialized in Embedded software, Hardware engineering and verification and Validation

Services Spread

HCL engages with customers from concept/idea generation stage to design and development and New Product Manufacturing and Implementation. We offer specialized services in mechanical Engineering, Medical imaging, Compliance testing, Independent Validation Verification, Prototype Development and Reliability Analysis.

HCL has executed turnkey development projects for new products as well as provided discrete services for existing products. Our embedded product lifecycle services provide:

  • Concept/Idea Generation: Market Requirements, User, Market Technical Research, Feasibility Studies, Concept Directions, Functional Specifications, Feature Benchmarking, Human Factors Consideration, Mock-Ups and Preliminary Proof of Concept

  • New Product Design Development: Feasibility study, architecture, modeling design, development, release management

  • New Product Adaptation: Re-development re-engineering, new technology adaptation, performance and reliability improvement, and multiple platform porting services

  • Product Sustenance: Lifecycle enhancements, defect tracking and fixing, feature enhancements, regression testing, and maintenance release

  • Independent Verification Validation: Software Verification, Mechanical Verification, Electrical Verification, Systems Verification, Systems Validation, OTS/COTS/Tools, Particular Std Testing and compliance testing

For more information, write to us at: contact.lsh@hcl.com

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Innovation in Medical Devices
Innovation in Medical Devices – Embedded Blood Glucose Meter in Smartphones

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Engineering and R&D Services (Medical Devices)
Engineering and R&D Services (Medical Devices)
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We will treat any information you submit with us as confidential. Please read our privacy statement for additional information.