Overview
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 HCLTech, 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
Insights
An overview of MEDDEV 2.7.1 Rev. 4, the latest clinical evaluation guidance released by European Commission
An overview of usability engineering and its impact on legacy medical devices
Establishing a unique complaint handling process to improve user safety, regulatory compliance and customer satisfaction
An overview of Test Method Validation Regulations and effective methods of implementing them
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.
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.
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.
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