Concept generation / Ideation
Tata Elxsi provides concept generation and validation and has a team of ethnographers, usability experts, and demography experts. We work with our clients in gathering market requirements, understanding the voice of the customer, usability research, human machine interface, technology feasibility, creating preliminary proof of concepts, etc.
New Product Development
Tata Elxsi has in-depth expertise in product development involving system architecture & design, system modeling, hardware design, software design, hardware and software integration, GUI development, connectivity solutions, and rapid prototyping.
Verification & Validation
Tata Elxsi has well established and proven verification & validation processes and methodologies. Our verification methodology helps our customers build highly scalable, reusable, and extensive verification environment which provides maximum functional coverage.
Tata Elxsi works on value engineering, re-engineering, and feature enhancement projects for different segments of medical devices. Our expert team follows an institutionalized process on project management; retain the best practices in knowledge management and re-training to facilitate SLA assurance and skill retention.
In conjunction with our engineering,design and development of medical devices, Tata Elxsi has a proven expertise in regulatory compliance for all categories of medical devices. We provide the services to meet the approval criteria of governing regulatory agencies of USA, Europe, Japan and other emerging markets like Brazil, India and China.
Tata Elxsi is ISO 13485 certified design house for medical devices. Tata Elxsi’s quality management system meets the requirements of ISO 13485:2003, ISO 9001:2008.
We help Original Equipment Manufacturers (OEM ) and Own Brand Manufacturers (OBM) of Medical Devices in meeting the compliance requirement of ISO 13485:2003, ISO 9001:2008, ISO 14971:2007, IEC 62304:2006, IEC-60601, 21 CFR Part 11 and 21 CFR Part 820 (QSR) Standards, CE & EU directives.
Services we offer:
- Gap Analysis & Assessment- Regulatory guideline compliance (USA, Europe, Japan other emerging markets)
- Documentation support for 510 (K) / Pre-market approval (USA, Europe, Japan, emerging markets)
- Design & development-Risk based approach for validation (ISO 14971)
- Maintaining & updating design dossier for higher risk classified devices
- Maintaining of DHF/DMR-(Identification & Traceability)
- Labeling / Instruction manual / SOP
- Post market surveillance support
- CAPA support
- RoHS / REACH compliance
- IEC 60601- 3rd edition , HSPM (IECQ QC080000) standard adherence
- Process Validation- DQ/IQ/PQ/OQ Computer System Validation (CSV)
- Support for Sterilization Validation ETO-ISO 11135, Gamma radiation-ISO 11137, Sterilization, Bioburden and microbial testing as per ISO 11737
- Biocompatibility (ISO 10993) & compilation of clinical data
- Clinical Investigation / Evaluation and report
- Pre-compliance testing (EMI/EMC)