American Medical Device Summit | HCL Technologies

Overview

Global Healthcare industry is driving towards better outcomes for patients and push from multiple regulatory agencies globally is fuelling 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 HCL Technologies, 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.

HCL 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 19+ years of experience in Medical Devices, HCL is partner to 9 out of Top 10 global medical device companies, engineered 150 + 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, HCL has inhouse Regulatory Center of Excellence which has 250+ industry experts with 10+ years of domain experience, having hands on experience with Electromechanical devices, Implantables, Disposables, Surgical Instruments, IVD and Combination Devices. HCL Medical device division is ISO 13485 certified.

To Experience Engineering Excellence and learn how you can leverage our services, meet us at booth 23 at AMDS 2019

For more information, please reach out to us at ERS.Info@hcl.com

Our Services

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MDR Compliance Services

Learn how HCL's MDR Compliance Services can help to streamline your MDR journey with an efficient approach.

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IVDR Compliance Services

Get a simplified and time bound approach towards IVDR Compliance

  • Assessment
  • Prioritization
  • Transformation
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CARE – Connected Assets in Regulated Environment

Get our comprehensive solution for accelerated application development

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

Insights

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COMPLAINT HANDLING FOR MEDICAL DEVICES

Establishing a unique complaint handling process to improve user safety, regulatory compliance and customer satisfaction.

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TEST METHOD VALIDATION FOR MEDICAL DEVICES

An overview of Test Method Validation Regulations and effective methods of implementing them

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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.

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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. 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.

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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.

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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