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Medical Devices and Diagnostics

 

Optimize your R&D and quality expenses, ensure regulatory compliance and quality assurance, and accelerate New Product Introduction (NPI) with TCS’ Medical Devices and Pharma Manufacturing Solutions.

The TCS Advantage

In-depth Experience: TCS has over 25 years of product and process engineering experience, large industry domain breadth and market presence. Having worked with 8 of top 10 device manufacturers, we provide you with radical solutions to optimize processes and maximize efficiency.

Culture of Innovation: TCS’ in-house R&D organization has undertaken path-breaking research programs using its Co-Innovation (COIN™) model with more than 20 Innovation Labs across the globe.  

Quality Conscious: TCS is ISO 13485 certified and has over a decade of rich experience in providing engineering solutions to medical device and pharmaceutical companies.

Strategic Alliances: TCS’ unique networks, a combination of alliances with the Tata group companies as well as external strategic alliances with global leaders in respective domains, cultivate true end-to-end engineering solutions for medical device companies.

End-to-end Solution Suite: Our integrated portfolio offers concept-to-launch product development, post market, regulatory and quality, product lifecycle management services for class 1,2,3 devices and manufacturing and go-to emerging market solutions.

TCS’ End-to-End Services

We provide the following services across the value chain:

New Product Development and Introduction

  • VOC, ideation, concept desing and development, product engineering and mechtronics
  • Engineering simulation
  • Prototyping
  • Packaging, plastics engineering
  • Validation and verification
  • Value analysis
  • Pre-clinical testing

Learn more about our NPI engineering solutions.

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Product Lifecycle Management (PLM)

  • 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

Learn more about our PLM engineering solutions.

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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

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Post Launch Activities

  • Post market surveillance
  • Sustenance engineering
  • Obsolescence management
  • Value engineering
  • CAPA
  • Design assurance line extensions

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Emerging Markets Offerings

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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

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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

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 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

White Papers

The Internet of Things for Medical Devices- Prospects, Challenges and the Way Forward

Take a look at the prospect of Internet of Things (IoT) for medical devices, the challenges and the way forward. Explore how a service oriented platform based approach can address these challenges.

Case Studies

TCS’ Managed Services Model Helps a Pharmaceutical Giant Optimize its IT Quality and Compliance Services

Learn how TCS helped a large pharmaceutical company reduce the complexity and costs of its IT Quality and Compliance (Q&C) operations by mitigating risk from potential compliance gaps and providing continual process improvement.

Analyst Reports

TCS Helps Pharmaceutical Manufacturer Implement Successful Mobility Solution

In this ARC View report, ARC Analyst, Janice Abel, writes about a case study that describes how TCS helped a major global pharmaceutical manufacturer implement a sales force mobility project using its rigorous and validated processes.

Other

Strategic Partnerships in Drug Development & Drug Safety

In this TCS viewpoint, featuring Gartner research, we present providers’ and consumers’ perspectives on driving efficiency and effectiveness in the drug development & safety cycle, with articles from industry subject matter experts, customers & research.