What keeps you up at night?
How can the current healthcare and medical device infrastructure meet the requirements of a growing global population? The simple answer is that it can’t. Providing scalable and affordable solutions to patients will require new approaches to leveraging technology. Is your company prepared to help lead the way?
Why should you consider HCL?
- Experience and expertise. As a recognized leader in the medical device outsourcing space, HCL provides fast and cost-effective end-to-end solutions across a variety of Class I, II, and III devices. HCL has been a partner to seven of the top ten medical device companies, working on over ninety products with zero recall. We have the largest dedicated medical device practice among Indian outsourcers and a manufacturing setup where we work with partners to provide cost-effective devices at scale to medical device companies.
- Quality systems and processes. HCL is the first Indian service provider to be ISO 13485 certified. HCL’s Medical Quality Management System (MQMS) meets the requirements of ISO 13485:2003, ISO 9001:2000, IEC 62304:2006, IEC-60601, 21 CFR Part 11 and 21 CFR Part 820 (QSR) standards, and conforms to FDA regulations. It is a mature and robust system which has been audited by independent auditors and customers. HCL’s Compliance Lab has been certified for ISO/IEC 17025.
- Product safety. HCL carries out ISO 14971 risk management processes and addresses safety standards and guidelines from ISO, IEC, AAMI, US FDA CDRH, and GHTF.
- Concept-to-Manufacture services. HCL offers medical device R&D and IT outsourcing services in areas like concept design, prototype development and validation, pre-clinical and clinical development, manufacturing and plant automation, sales and marketing, enterprise IT functions, and obsolescence management.
- Sound ecosystem. HCL has strong partnerships with individual clinicians as well as leading Indian institutions such as IIT and IISc. We have been a partner to the Confederation of Indian Industry (CII) committee on the establishment of regulatory guidelines for medical devices in India. Our in-house product engineering and product testing labs provide us with the necessary infrastructure to support medical device manufacturers. We have dedicated Centers of Excellence in industrial design, imaging, reliability engineering, wireless design, user interface design, mobility industrial design, FEA, and IV&V.
- Comprehensive IT solutions. For over thirty years, HCL has been providing IT solutions across application managed services, application testing, CRM, aftermarket services, infrastructure management, business process outsourcing and product life cycle solutions. Our “ALT ASM” solutions have helped clients reduce their IT costs by over 30% and have helped ensure a seamless and transparent model that links service level agreements to business-level KPIs.
- Enterprise Application Services. HCL’s acquisition of AXON combined the best of AXON’s strong business consulting and implementation capabilities and HCL’s robust global delivery-based application and infrastructure management capabilities. We deliver unique value on an end-to-end basis for SAP, Oracle, and Microsoft customers, ensuring that they receive the optimal business transformation solution at the right price.
- Richer mobility experience. HCL’s mobility solutions enable organizations to become highly productive and customer centric by making information available at the right time to the right person – all through a simple click. HCL’s Mobility CoE offerings include mobile application development, enterprise mobile offerings, system integration services, and managed services. Key current partnerships include Sybase and RIM. HCL is investing in this space with initiatives such as the Network Solution Lab, a dedicated mobility center in Singapore, and through alliances with several universities.
How can HCL help you?
Our services include hardware engineering, firmware and embedded software development, verification and validation, mechanical engineering, industrial design, tooling, GUI design, system integration and testing, DFx analysis, prototyping, test engineering, regulatory compliance support, and documentation.
We provide three categories of services to medical device companies:
- New-product introduction: Product conceptualization; design, development and testing; regulatory compliance
- Value analysis and engineering: Cost reduction, size reduction/miniaturization, re-engineering products for engineering markets, feature enhancements, interoperability initiatives
- Continuity and end-of-life engineering: Sustenance engineering, end-of-life support, obsolescence management, porting, migration, modernization, RoHS/IEC – 3rd edition, compliance
Engineering and R&D Services (Medical Devices)