MDR-IVDR Awareness

The focus of Global Healthcare Industry is on -meeting the increasing demand for healthcare services and reducing the rising cost of those services. Global healthcare is being driven by the health needs of aging and growing populations, the rising prevalence of chronic diseases, emerging-market expansion, building connected solutions, and treatment and technology advances. Innovations changing the landscape of the healthcare Industry are bringing the Patient at the Center of Healthcare ecosystem.

The Global Healthcare Industry is going through a shift. Medical Devices companies are now building solutions / products keeping Patients at center and are focused on building customer centric product strategies with aim to provide trouble-free experience to the patients.

HCLTech’s medical device practice has extensive experience and expertise of working on vast array of medical devices- ranging from complex electromechanical devices to disposables, surgical equipment to Implantable Devices (Active & Non-Active), Point of Care, In vitro diagnostics (IVD) and Lab Diagnostics Devices to connected device ecosystem. As a product engineering, sustenance and regulatory partner of choice to 9 of the top 10 medical devices companies, HCLTech delivered innovation at a predictable cost model. HCLTech has a track record of working on 100+ medical devices across class I, II and III successfully.

HCLTech works on New Product Development, Product Sustenance, Regulatory and Compliance, New Technology Adoption (IoT, Medical Mobile Apps, Cloud Enablement) and more.

Key Highlights:

• HCLTech is the preferred engineering partner to 9 of the top 10 medical devices companies.
• 2500+ experienced engineers, dedicated to the Medical devices and diagnostics domain
• Knowledge and successful execution of 100+ devices, ranging from Class I,II, III
• Strong local presence in Europe with 10+ delivery centers
• 16 years of experience in medical devices alone. Several complex mission-critical electro-mechanical/ mechanical products developed from concept to launch
• Mature project and risk management processes with QMS confirming to FDA and European regulations audited by the world's leading medical OEMs
• $25Mn+ investment into generic as well as functional labs
• Partnerships with institutes such as Human Factor International, IITs, IISCs and engineering partner to Johns Hopkins University. Participant in Confederation of Indian Industries (CII) committee on regulatory guidelines for medical devices in India
• Largest Engineering Team globally
• INTEGRATED DESIGN SERVICES- Electrical, Mechanical, Software, System and Regulatory