HCL's Medical Device Practice
HCL's Medical Device practice at HCL is a dedicated micro-vertical that acts as a One-stop shop for medical device manufacturers. HCL is a recognized leader in the medical device outsourcing space, providing fast and cost effective end-to-end solutions across a variety of Class 1, 2 and 3 devices.
HCL offers "Concept to Manufacture" Medical Device R & D & IT Outsourcing Services in areas such as: concept design, prototype development & validation; pre-clinical and clinical development; manufacturing and plant automation; sales & marketing; enterprise IT functions; and obsolescence management.
Our device to application integration CoE and a strong regulatory practice provides regulatory support at every stage of the lifecycle.
- Largest Dedicated Medical Devices practice amongst Indian Outsourcers
- First Indian service provider to be ISO 13485 certified
- HCL's dedicated Medical Quality Management System is a mature and robust system. It has been audited by several independent auditors and customers over the last several years
- HCL compliance Lab is certified for ISO/IEC 17025
- 19 Top Medical Device customers
- HCL has worked on 80+ Medical Devices
- A team of 776+ domain experts and consultants
- Experience - HCL works with 7 of the top 10 global medical device OEM's
- Quality System - HCL Medical Quality Management System (MQMS) meets the requirements of ISO 13485:2003, ISO 9001:2000, and 21 CFR Part 820 (QSR) standards
- Product Safety - HCL carries out Risk Management processes as per ISO 14971 and addresses safety standards/guidelines from ISO, IEC, AAMI, US FDA CDRH, GHTF
- Process Compliance - Service offering for CSV and 21CFR Part 11 compliance expertise strengthened by Regulatory Affairs Certified (RAC) Consultants
- Proven Product Development Process - As per US-FDA as well as MDD
- Product documentation meet 510(k), IDE, and CE Marking requirements
Service Offerings
HCL's Medical device practice takes leverage of its rich and strong Product Engineering capabilities, HCL's service offerings offer solutions in areas like:
Concept, Design, Prototype and Validation: We engage with customers from concept/idea generation stage to design and development, New Product Manufacturing and Implementation, compliance testing, Independent validation & verification, Prototype Development.
Pre-Clinical and Clinical: Our Clinical development offerings help you reduce your clinical trial and data management costs with unique service offerings like clinical trial management, clinical data management and data analytics services.
Regulatory Compliance: Our regulatory compliance services help you achieve approvals at a faster pace with lower TCO. We help you in ensuring compliance towards validation of all applications and meeting regulatory requirements and quality policy implementations. We also support you in automating the Regulatory submissions for marketing authorization of Medical Devices.
Manufacturing IT: Our manufacturing and plant automation services help you reduce TCO, achieve regulatory compliance, decrease time to market and enhance productivity.
Sales & marketing: HCL's consulting services, Sales support solutions, Sales Force Management and Marketing Management services help reduce your sales & marketing spends.
Enterprise IT: HCL's customized ERP, Middleware and Content management solutions help you transform your business and create an integrated IT environment. Our Enterprise Consulting services focus on improving your enterprise IT performance through analysis of existing business problems and development of Roadmaps and Business Strategies.
Obsolescence Management & Legacy IT: HCL offers Active product Support, End of Life (EOL) services, globalized Life Cycle services and regulatory compliance services that aims at extending the maturity stage of the your product life cycle.
