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Global Healthcare industry is going through a shift with the recently updated/ reformed MDR (Medical Device Regulations), that are responsible for regulating firms who manufacture, repackage, relabel or purchase medical devices. The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities.
We at HCL Technologies, an $8.5bn global Technology company, help create value for the healthcare ecosystem. We have helped our customers develop new revenue streams of more than $1bn.
We take this opportunity to help you:
1. Get a simplified and time bound approach towards MDR compliance
2. Enable time-bound compliance with our Process Validation Services
3. Improve and Optimize Medical Device plant productivity through our best-in-class Manufacturing Engineering Services
4. Drive innovation in medical devices and diagnostic instruments
We invite you to meet us at Generis American Medical Device Summit (AMDS) 2018 to Experience our world class frameworks, solutions and accelerators. It will be our privilege to discuss how we can help you shape your Next-Gen vision on MDR and make it a reality!
To Experience Engineering Excellence and learn how you can leverage our services, meet us at booth 48/51 at AMDS 2018.
For more information, please reach out to us at ERS.Info@hcl.com
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
DESIGN HISTORY FILE REMEDIATION FORMEDICAL DEVICES
A Design History File (DHF) is a compilation of documentation that describes the design history of a finished medical device. The Design History File encompasses the objective evidence that the design has been developed in accordance with the Design and Development Plan, in compliance with regulatory requirements and design control requirements.
IN VITRO DIAGNOSTIC REGULATION(IVDR) OVERVIEW
The new and stringent requirements related to clinical evidence has already created chaos among the industry. It necessitates the manufacturer to go through the existing evidence and ensure that it is in compliance with the new definitions and performance evaluation requirements set by IVDR.
OVERVIEW OF EUROPEAN MEDICAL DEVICE REGULATIONS
The latest change in the European Medical Device Regulations is going to affect the operation of different entities ranging from economic operators, manufacturers, service providers, competent authorities, and European Institutions. The changes are seen with a positive intent by the Medical Device Industry and it is believed that the changes will open new doors for innovation and safer development of medical Devices.
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 HCL 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 HCL can help achieve compliance in a time bound & cost effective manner.
NEW AGE 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 HCL 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 HCL is helping IVD and Lab diagnostics companies address these challenges.
Your NEW AGE Product Engineering Partner
HCL, 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 HCL is preferred Product Engineering partner to 9 of the top 10 Global Medical Devices companies.