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.
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.