Medical Devices
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.
Practice Highlights
- 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
- HCL has worked on 80+ Medical Devices
Why HCL?
- 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
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