Overview
Global Healthcare industry is driving towards better outcomes for patients and push from multiple regulatory agencies globally is fueling this new trend. OEM's are on their heels to make their products compliant to MDR/IVDR. To deliver better outcomes to patient, it became a necessity to map the entire patient journey which prompts a need for OEM's to partner with vendors, capable of supporting the new industry requirements.
We at HCLTech, an US$ 12.3bn global Technology company, help create value for the healthcare ecosystem. We have helped our customers develop new revenue streams of more than $1.6 bn.
HCLTech Engineering and R&D services for Medical Devices industry, span the entirety of product lifecycle, right from ideation, development to product commercialization and supply chain.
With 20+ years of experience in Medical Devices, HCLTech is partner to 9 out of Top 10 global medical device companies, engineered 160 + Class I, II and III Medical Devices with a team of more than 5000+ experienced professional having competencies in field of Mechanical, Electrical, Industrial Design, Regulatory services, Application & Embedded Software, Digital, Testing, Supply Chain and Manufacturing.
Regulations forms the backbone of medical device industry and with that in mind, HCLTech has inhouse Regulatory Center of Excellence which has 275+ industry experts with 10+ years of domain experience, having hands on experience with Electromechanical devices, Implantables, Disposables, Surgical Instruments, IVD and Combination Devices. HCLTech Medical device division is ISO 13485 certified.
To Experience Engineering Excellence and learn how you can leverage our services, meet us at AMDS 2020
For more information, please reach out to us at ERS.Info@hcl.com
Our Services
Learn how HCLTech MDR Compliance Services can help to streamline your MDR journey with an efficient approach.
Our Regulatory and Clinical CoEs bring in right domain expertise to provide simple and efficient approach to ensure regulatory and quality compliance.
Get our comprehensive solution for accelerated application development
- Micro Services Architecture
- Packaged Application Framework
- Re-usable Software components
HCLTech Post Market Surveillance CoE offerings cover a large gamut of sections that includes complaint handling, vigilance and trend reporting, value-added services, and enablers & accelerators.
Insights
Establishing a unique complaint handling process to improve user safety, regulatory compliance and customer satisfaction.
Tremendous rise in new drug development cost every passing year, puts an extreme pressure on the drug discovery, leading to the need for evidence based data driven approach for clinical trials.
The 21st Century Cures Act issued on March 9, 2020 by ONC and CMS has some major implications for health insurers who offer Medicare.
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.
An overview of MEDDEV 2.7.1 Rev. 4, the latest clinical evaluation guidance released by European Commission.