To meet the challenges of growing regulatory oversight, the need for complete concept to end-of-life product traceability and faster time to market, clients leverage Wipro’s PLM service for Medical Devices. The service includes:
- Quality and Compliance Management: Regulatory authorities such as FDA and EMA strictly enforce standards related to Quality Systems Regulations (21CFR Part 820) and Electronic Records & Signatures (21CFR Part 11). Wipro’s PLM group leverages its ISO 13485:2003 certified EngineeringNXT Practice to deliver solutions that address quality and compliance needs. Wipro also delivers validated PLM solutions for DQ, IQ, OQ and PQ requirements.
- Integrated Product Development: Wipro is a pioneer in the area of Mechatronics Product Development and has proven experience in delivering integrated mechatronics process management solutions. We helps clients achieve a collaborative product development environment with Systems engineering along with Requirements management. These scalable solutions support emerging trends such as Additive Manufacturing and connected product ecosystems.
- Service Lifecycle Management: As an outcome of products getting smarter, connected and personalized, SLM based solutions have become critical to realize remote management of devices. Wipro has built capabilities around Service Management, IoT and Digital Twin to help clients achieve better utilization of devices while maintaining optimal costs and profitability. Wipro enables companies achieve true “Closed Loop Change Management” by capturing real-time product feedback.
- Unique Device Identification (UDI) Compliance: The service facilitates integration of product codes and field data in a connected ecosystem. Wipro leverages its strong partnerships in IoT and SLM to enable UDI integration in the enterprise landscape.
- Collaborative Design and Engineering: Wipro implements foundation PDM/PLM solutions to enable Part/Doc Management, CAD integrations, Engineering Change Management and Collaboration with the extended enterprise leading to rapid design and delivery of new products that meet the highest quality standards.