Engineering Today, for Better Tomorrow | HCLTech

Engineering Today, for Better Tomorrow


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 (specifically, 6 out of the 10 best IVD companies), HCLTech has delivered innovation at a predictable cost model. HCLTech has a track record of working on 150+ medical devices across class I, II and III and IVD devices across Class A, B, C & D.

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 and 6 out of Top 10 IVD companies
  • 3800+ experienced engineers, dedicated to the Medical devices and diagnostics domain
  • Knowledge and successful execution of 150+ devices, ranging from Class I,II, III and Class A, B, C & D
  • Strong local presence in Europe with 10+ delivery centers
  • 18 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
  • $50Mn+ investment into generic as well as functional labs
  • Partnerships with institutes such as Sri Ramachandra Institute, Human Factor International, IITs, IISCs for collaborative Medical Device R&D programs, Utilization of Central Diagnostic Laboratory at the Medical Centre, Animal Testing through Centre for Toxicology and Developmental Research (CEFT), Clinical Trial, Wet Laboratory Testing, Exchange of Knowledge & Experts support for Specification Development, Usability, Risk Assessment and engineering partner to Johns Hopkins University.
  • Participant in Confederation of Indian Industries (CII) committee on regulatory guidelines for medical devices in India
  • INTEGRATED DESIGN SERVICES- Electrical, Mechanical, Software, System and Regulatory

For more Information, click here to download our brochure

Schedule a Meeting

Our Offerings

IVDR compliance

Get a simplified and time bound approach towards IVDR Compliance

  • Assessment
  • Prioritization
  • Transformation
Smiley face
CARE Platform

Get our comprehensive solution for accelerated application development

  • Micro Services Architecture
  • Packaged Application Framework
  • Re-usable Software components
Sustenance Engineering Services

Get HCLTech’s best-in-class Sustenance Engineering Services

  • Functional Expertise
  • Frameworks and Accelerators
  • Complete ownership of sustenance

IVD Handbook


Want to take a deep into the changing IVD landscape? Here is a comprehensive IVD handbook to give you plethora of information. Get insights from our SMEs and read what they have to say on aspects like Market influence on defining IVD product strategy, IVD regulations, Tracking Global Regulations, Imperatives for compliance, saving time and clinical validation expenses, Impact on private label manufacturers and kits, QMS process, Approach to control complex PMS process, Finding the right notified body and Change Management.

Click here to know more.


Complaint Handling for 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
Test Method Validation for Medical Devices
An overview of Test Method Validation Regulations and effective methods of implementing them
Design History File remediation for Medical Devices
Design History File remediation for Medical Devices
A Design History File (DHF) is a compilation of documentation that describes the design history of a finished medical device.
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.
IVDR Challenges and Approach for Implementation
An overview of all the challenges that businesses might face due to IVD Regulations and what approach should be followed to ensure timely compliance.
Digital Healthcare for Rural India
Digital Healthcare for Rural India
An insight on how a quality health care infrastructure can be built for Rural India with the help of Digital Technology.
Providing preventive
Providing preventive and curative care with the help of Digital Healthcare
An overview as to how latest Digital Technology and services can be leveraged by Healthcare organizations and government to optimize their care services delivery.