MDR-IVDR Awareness | HCLTech

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

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Medical devices clinical evaluation reports

An overview of MEDDEV 2.7.1 Rev. 4, the latest clinical evaluation guidance released by European Commission

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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 HCLTech can help in your MDR\ IVDR journey.
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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 HCLTech can help achieve compliance in a time bound & cost effective manner.
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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 HCLTech can help increase productivity and compliance in Manufacturing.
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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 HCLTech is helping IVD and Lab diagnostics companies address these challenges.
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Your NEW AGE Product Engineering Partner
HCLTech, 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 HCLTech is preferred Product Engineering partner to 9 of the top 10 Global Medical Devices companies.