Medical Devices & Life Sciences

Enabling Connected Care Ecosystem

As the medical devices and healthcare industry is experiencing rapid transformation, the companies need to adopt a strategic approach to drive innovation that addresses market needs and challenges. Capgemini’s medical device engineering practice brings solutions and services that help our clients to deliver customized, cost-effective, and patient-centered care for enhanced clinical outcomes and collaborate through the complete medical device value chain. 

Medical devices are becoming more connected than ever and are shaping new solutions to offer value for healthcare such as improved quality of life for patients with chronic illnesses, and reducing cost of treatment. Leveraging next-generation technologies we help clients retain their competitive edge by:

  • New business models with focus shifting from being device-centric to patient-centric healthcare
  • Rationalization of cost and improvement of operational efficiency across the product development and manufacturing lifecycle to address the cost pressures
  • Increased regulatory rigor in management of product safety, performance and security
  • Growing emerging markets, driving localization and value engineering initiatives

Our Key Offerings

Connected Products

  • Smart Product and System Development
  • Software Product Engineering
  • Healthcare IT and Interoperability Services
  • Smart Product Support

Smart Engineering

  • Systems Development
  • Mechanical and Physical Engineering
  • Product and System Testing
  • Technical Publication and Product Documentation

Digital Manufacturing

  • PLM
  • Virtual Engineering
  • Smart Factory

Quality Assurance and Regulatory Affairs for Medical Devices (QARA)

  • Product and Process Compliance
  • Compliance Support for EU MDR and IVDR
  • Technical Documentation and Reporting

Remediation Services to help regulatory compliance for medical device companies

Our Focus areas

Key Differentiators

  • Industry Leadership
    • 18+ years of experience
    • 250+ regulatory submissions
    • Experience in 35+ clinical categories
    • Alliance partnerships with AWS, Microsoft, Google, IBM, PTC
  • Medical Standards and Certifications
    • Process and quality compliance: ISO 13485, 14971, IEC 62304
    • Regulatory compliance: FDA CFR IEC 60601, IEC 62366, RoHS, HIPPA, EU MDR/IVDR
  • Assets and Accelerators:
    • iDiagnose – Deploying deep learning algorithms in medical imaging applications
    • iHeal – Engineering analytics framework for predictive, preventive maintenance to enable auto healing
    • HL7 Connector Framework: Interoperability among proprietary applications to exchange clinical and administrative information

Thought Leadership

EU-MDR Implications and way forward

Learn about Capgemini’s framework for a successful transition to MDR taking a structured...