Medical devices clinical evaluation reports
An overview of MEDDEV 2.7.1 Rev. 4, the latest clinical evaluation guidance released by European Commission
Application of Usability Engineering for Legacy Medical Devices
An overview of usability engineering and its impact on legacy medical devices
Complaint Handling for Medical Devices
Establishing a unique complaint handling process to improve user safety, regulatory compliance and customer satisfaction
Test Method Validation for Medical Devices
An overview of Test Method Validation Regulations and effective methods of implementing them
MDR and IVDR Compliance services
MDR poses number of challenges to medical firms - stringent evaluation, increased safety & performance proof needs, increased auditing & inspection, more clinical data, EUDAMED database, to quote a few amongst them. Learn how HCLTech can help in your MDR\ IVDR journey.
Best-in-class Process/product validation services
Regulatory Compliance issues and warning letters from notified regulatory bodies can derail your organization’s priorities. Various challenges can make it a daunting task to bring back things on track. Learn how HCLTech can help achieve compliance in a time bound & cost effective manner.
21st Century Manufacturing Engineering services
Digital revolution is disrupting the manufacturing space. Advancement in Automation, Artificial Intelligence, Additive Technology and IOT, demand the depth and width of capabilities to be realized in the Digital Manufacturing space. Learn how HCLTech can help increase productivity and compliance in Manufacturing.
Medical Devices and Diagnostics Instruments engineering services
Is IVD Regulation, New Product development & sustenance, device integration with care ecosystem and adoption of new age technologies like Mobility, IoT, Analytics, etc. on your radar? Learn how HCLTech is helping IVD and Lab diagnostics companies address these challenges.
Your 21st Century Product Engineering Partner
HCLTech, over the last 16+ years, has delivered significant Time to Market advantage and cost effective engineering solutions to top global Medical Devices companies. Learn why HCLTech is preferred Product Engineering partner to 9 of the top 10 Global Medical Devices companies.