Engineering & Industrial Services

Regulatory Services for Medical Devices and Diagnostics Industry

TCS offers you comprehensive and best-in-class regulatory solutions and services that enable you to rapidly commercialize and effectively sustain brands in a compliant and cost-efficient manner.

A highly competitive and regulated industry such as Medical Devices & Diagnostics (MD&D) necessitates processes that are accurate and quality compliant. Keeping pace with the dynamic regulatory climate imposes an additional cost burden. Further, organizations need to be capable of ensuring post-market regulatory compliance for effective product sustenance.

Our Solution

TCS Regulatory services group has a strong background in global regulatory matters. Our comprehensive services include:

  • Regulatory dossier preparation for global regulatory audience
  • RoHS and EHS compliance
  • Post-launch regulatory compliance comprising of CAPA,
  • Customer-complaint management
  • Change management and development-customization-implementation of compliant software solutions


Our solutions provide you with benefits such as:

  • Ensure total compliance to various global medical device regulations
  • Obviate rework through our 'get it right the first time' approach
  • Software solutions that are compliant with 21CFR part 11
  • TCS GNDM model ensure maximum savings; upto 90% offshore for regulatory affairs & 50% offshore for Regulatory Compliance
  • Extensive regulatory experience in both paper-based & electronic  systems

The TCS Advantage

TCS is ISO 13485 certified and has been providing engineering solutions to 8 of top 10 Medical Devices companies. TCS ensures to address regulatory affairs and compliance needs through:

  • Domain expertise: Our experts bring in strong competencies in regulatory affairs, regulatory submissions and medical writing. through the execution of numerous successful assignments.
  • Customized solutions: We offer customized solutions in leading PLM systems like Teamcenter for
    Medical Devices and Quality Management Systems.
  • TCS Networks: Our partners are well-versed with the nuances of local regulations and manage local language conversions, local testing requirements & labeling related matters seamlessly.

Reach Us.