The medical devices industry is in a state of constant evolution owing to new innovations and regulations. This has led to the development of devices and solutions which have revolutionized patient care. The key trends include miniaturization & portability, connectivity & remote patient monitoring, and reliability & affordability.
Tata Elxsi provides design and engineering services to the medical devices industry. We understand the changing trends in this industry and offer services such as concept generation & validation, product development, verification & validation, and sustenance engineering.
With a unique focus on product design and engineering services, we provide services across the product development lifecycle. We have leveraged our cross functional domain expertise in the areas of connectivity technologies (Bluetooth, Wi-Fi, wireless), mobility solutions, and industrial design to provide cutting edge solutions to our clients spanning diagnostic devices, surgical devices, point of care devices, telemedicine solutions, and medical imaging solutions.
Medical Device Practice Ecosystem:
- Product Prototyping
- Compliance Testing Labs
- Hospitals & Educational Institute Tie-ups
Our service offerings include:
- Concept/ Idea Generation: Market requirements, user, market & technical research, feasibility studies, concept directions, functional specifications, feature benchmarking, human factors consideration, mock-ups and preliminary proof of concept.
- New Product Design & Development: Feasibility study, architecture, modeling & design, development, release management.
- New Product Adaptation: Re-development & re-engineering, new technology adaptation, performance and reliability improvement, and multiple platform porting services.
- Product Sustenance: Lifecycle enhancements, defect tracking and fixing, feature enhancements, regression testing, and maintenance release.
- Independent Verification & Validation: Software verification, mechanical verification, electrical verification, systems verification, systems validation, OTS/COTS/Tools, particular Std testing and compliance testing.
- Regulatory compliance: RoHS/ REACH compliance, CAPA support, 510 (K)/ Pre-market approval, post market surveillance support, process validation- DQ/IQ/PQ/OQ Computer system validation, maintaining of DHF/ DMR (CSV), IEC 60601- 3rd edition, HSPM (IECQ QC080000) standard adherence, pre-compliance testing (EMI/EMC).
Our areas of expertise include:
- Board design
- Algorithm development & optimization
- Image processing & visualization
- Firmware/ middleware development
- Software application development
- GUI development
- Connectivity & mobility solution
- Industrial & mechanical design
- Human factors engineering
- Usability engineering
Tata Elxsi is an ISO-13485 certified product design house. Our quality management system, tailored to the medical device industry meets the requirements of ISO 13485, ISO 14971, ISO 9001, IEC 62304, IEC-60601, 21 CFR Part 820, CE & EU directives and other equivalent requirements.