Tata Elxsi recognizes the efforts and expertise that goes into developing a product and its technical dossier that is why our dedicated team of industry trained regulatory consultants act as customer’s extended support arm to minimize risk associated to product development, sustenance and internal processes.
Our team of consultants and back-end QA/ RA experts add value by setting-up an optimized process for development, testing, validation, document submission, post market activities as well as internal transitions.
We bring over 20 years of deep industry experience and in-depth understanding of device and region-specific regulatory complexities hence our support services across the value chain significantly help optimize processes, resources and associated costs.
Apart from regulatory compliance support across Product Development Lifecycle, Tata Elxsi also provides stand-alone support services such as:
- EU MDR & IVDR transition support services
- Process Validation Services
- Labeling and Packaging services
- Industry trained regulatory consultants
- Expertise across specific processes: ISO 13485, ISO 14971, FDA QSR 21 CFR 820, IEC 62304
- Readily available workflow templates for (IDE, PMA, 510K, CE), traceability and reporting and UDI compliance
- Experience in regulatory submission support of Class I and Class II devices with complete coverage of the regulatory landscape
- ISO 13485:2003
- ISO 9001:2008
- ISO 27001:2013
“Tata Elxsi has helped in implementing the project successfully and has exceeded expectations on all fronts. They have groomed a high performing regulatory team that is a key differentiator for Tata Elxsi.” – Bio-therapeutic Major