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Medical Devices and Pharma Manufacturing


Medical devices & process outsourcing helps navigate many challenges the device industry faces today. Pharma majors must upgrade and optimize their manufacturing operations and focus on quality and regulatory compliance.

TCS delivers strategic, innovative and cost efficient solutions to 8 of the top 10 life sciences companies through its dedicated Global Engineering Centers. It is a trusted partner to accelerate profitable growth for medical device OEMs & pharma manufacturers.

Client Challenges

  • Reducing the time-to-market for new products
  • Handling pricing pressures
  • Coping with impact of healthcare reforms
  • Optimizing R&D spends
  • Enhancing the quality of products and processes
  • Adapting to the global regulatory environment
  • Capturing and growing in emerging markets

What TCS Provides

TCS is an ISO 13485-certified organization. We provide product development and process outsourcing, manufacturing operations and IT transformation and support. Our services include the following:

  • New Product Development & Introduction:  
    • VoC, ideation, concept design & development, product engineering and mechatronics
    • Engineering simulation
    • Prototyping
    • Packaging, plastics engineering
    • Validation and verification
    • Value analysis
    • Pre-clinical testing
  • Manufacturing Operations Management:
    • Manufacturing IT applications
    • Portfolio rationalization
    • Manufacturing intelligence
    • Manufacturing Execution systems (MES)
    • Enterprise Asset Management (EAM)
    • Control systems integration
    • Process optimization and analytics
    • Sourcing
  • Emerging Markets Offerings:
    • Portfolio analysis
    • Outsourcing Strategy
    • VoC
    • Go-to-market business models
    • Low-cost product development and manufacturing
  • Post Launch Activities:
    • Post market surveillance
    • Sustenance engineering
    • Obsolescence management
    • Value engineering
    • CAPA
    • Design assurance line extensions
  •  Product Lifecycle Management:
    • Strategic road mapping
    • Technology selection
    • Multi-site roll-out
    • System integration
    • Technology maturity assessment
    • Lifecycle services
    • Platform migration and upgrade services
    • Solution accelerators and support / sustenance services
  •  Regulatory Compliance and Quality Assurance Services:
    • US FDA
    • EU MDD (CE)
    • MHRA
    • SFDA
    • MHLW
    • Design Control (Class I, II and III)
    • eDMR /eDHF /eDHR
    • CAPA
    • Complaints management
    • Quality management system
    • LIMS
    • Clinical trials management
    • Environmental compliance
    • ISO13485
    • IEC 60601 series
  • Medical Electronics and Technology Enrichment:
    • Embedded systems development
    • Miniaturization
    • GUI and HMI for DICOM solutions
    • Imaging  / visualization technologies
    • RFID
    • Smart devices
    • Diagnostics
    • Robotics
    • Automation and wireless technologies
    • Materials research
    • Predictive simulation
    • Mathematical modeling


  • Connected Health: TCS has developed connectivity and interoperability framework - Connected Health - based on the vision shared by Continua Health Alliance and aligns with medical / health device communication standard IEEE 11073.
  • Manufacturing Operations Transformation: TCS’ Manufacturing Operations Transformation (MOT) framework enables the standardization of platforms and processes, and drives vertical integration across the manufacturing lifecycle. Our framework helps initiate continuous enterprise-wide improvement programs, enable global rollouts at low cost and centralize support services to achieve plant-wise Manufacturing Operations Management benefits.
  • Engineering Process Services for Medical Devices and Diagnostics Industry: TCS’ full services framework for EPS is tailored to comprehensively meet the needs of medical devices and diagnostics companies. Our framework, spanning the entire product development lifecycle, can help you increase product development bandwidth while managing lean teams, reducing time to market and ensuring quality compliance.

Business Value

Capture emerging markets and attain a competitive advantage in the globally-regulated market place despite intense competition, increased scrutiny and cost pressures. Get the following business benefits with TCS:

  • Increased market share in emerging markets
  • Accelerated NPI with reduced time-to-market by 30-40% for next generation products
  • Accelerated IP creation with the rapid launch of new products and expansion of product portfolio
  • Launch of indigenous products for emerging markets and markets of the future
  • Sustenance engineering with cost savings up to 50%
  • Access to global talent at reduced costs with TCS’ Global Engineering Center for R&D shared services

Success Stories

TCS helped a global orthopedic major enhance its ability to help its core competent personnel focus on breakthrough innovation and increase their NPD output significantly. Simultaneously, we helped reduced the average time for an adverse event / complaint resolution from 6+ months to 23 days.

TCS assisted a leading drug device combination product reduce its cycle time in an automated polymer coating plant by over 30% and out of spec rejections by 18% by deploying a state-of-the-art manufacturing execution system tightly coupled with the control automation system and QA / QC Laboratory Information System. Simultaneously, this system created an electronic batch record and interfaced with the ERP for enterprise visibility to further enhance planning and production efficiency.

Client Thoughts

“It is said that an important factor for individuals to have a successful business environment around them is to have a best friend in the workplace. Certainly I believe that my TCS team acts as a best friend when I am in need of effective and rapid response to design issues, honest and dedicated effort in engineering support, and engaged and intelligent partnership in technical problem resolution.”
-Zimmer Inc.,
Director - Technical Services

“GSK has chosen to partner with TCS because of its strong record in knowledge process outsourcing, underpinned by operational excellence. I am confident our collaboration will benefit both partners and, most important, help to deliver new medicines to patients.” 
-GlaxoSmithKline, Dr Amber Salzman, 
Senior Vice President - Development Operations


TCS Networks, Dassault Systemes, Siemens SAP, Camstar, Microsoft, Oracle, ESRI, Apriso, Sparta Systems-TrackWise,A.C Nielson, Underwriters Laboratories Inc., Apollo Hospitals, Indian Institute of Technology - Madras, IISc, Massachusetts Institute of Technology, National Chemical Laboratories, Indian Institute of Packaging, Thermofisher

Associated Products


Medical Devices & Diagnostics and Pharma Manufacturing

Learn how TCS can help medical device OEMS and pharma manufacturers introduce high quality, innovative and differentiated products with up to 30% faster NPI, up to 40% cost containment and global sourcing.

TCS in the News

Systech International and TCS Partner to Help Medical Device Manufacturers Comply with UDI Legislation

The article highlights a new partnership between Systech International and TCS to supply medical device manufacturers with an end-to-end UDI solution as a means of complying with pending FDA Unique Device Identification (UDI) requirements.


PLM Solution for Medical Devices, Diagnostics and Pharma Manufacturing

Learn how TCS and the Siemens Product Lifecycle Management (PLM) software provides a product-centric approach, equipping you with the PLM capabilities and compliance, using automated best practices and workflows, enabling increased efficiency, reliability and the ability to configure new products faster.


Camstar Global Conference 2014 - The Global-Ready Enterprise: Seize Your Opportunity

TCS is a Gold Sponsor at Camstar Global Conference (April 27-30, 2014). Meet our executives to learn about TCS’ capabilities in Manufacturing Operations Management (MOM) across life sciences, high tech and energy industry segments.