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Read whitepaperStrategic Medical Device Complaints Management
The medical device industry is experiencing a heightened need for effective complaint handling due to increasing hazards from serious reactions and public threats. Regulatory bodies now enforce stringent timelines for submitting complaints, especially those involving serious public health threats, deaths, and significant events. Additionally, the growing awareness of evolving regulations and multiple sources of complaint reporting are shaping the industry landscape. Manufacturers face challenges such as handling large volumes of complex complaints, ensuring timely communication, managing complaints across various channels, and maintaining regulatory compliance.
Efficient data management and analysis are also critical for deriving meaningful insights from complaint data. Tata Elxsi addresses these challenges by offering end-to-end complaint management services tailored to meet specific strategic and financial needs. Our solutions significantly reduce manual efforts and costs while providing 24/7 operational capability and regulatory expertise, ensuring comprehensive support for medical device complaint handling, processing and compliance.
Transforming Complaint Management for Enhanced Medical Device Performance
Here’s How We Help
Handling complaints of varying complexity levels and high volume
- Refining end-to-end processes with Value Stream Mapping to minimize turnaround time, enhance complaint quality, and ensure compliance.
Efficient management of complaints across multiple sources
- Developing integrated systems to handle complaints from various sources, ensuring thorough coverage and swift resolution.
- Establishing standardized processes for documenting, reporting, and tracking complaints, enhancing transparency and accountability.
Optimizing resource utilization and cost reduction
- Leveraging accelerators and technology to reduce manual efforts and costs, enhancing operational efficiency.
- Maximizing resource utilization through cross-team deployment, providing 24/7 support for complaint processing while maintaining quality and compliance.
Medical Device Complaint Service Framework
The E.P.I.C complaints management framework delivers end-to-end complaint handling solutions that drive tactical advantage and long-term strategic value. Built on four pillars, Expertise, Processes, Impactful solutions, and Cohesive partnerships, the framework enhances operational accuracy, centralizes service models, simplifies processes, and supports CAPA compliance. With capabilities in automation, training, and centralized development, it ensures regulatory alignment, productivity improvement, and consistent customer satisfaction across regulated industries like medical devices, pharma, and consumer healthcare.
Capturing Tactical Advantage
The first half of the framework focuses on building tactical strength through expertise and processes. It brings domain experts, complaints handling COEs, and robust training frameworks to improve operational accuracy. Flexible engagement models, consulting for process simplification, and customer academies enable organizations to train, upskill, and streamline their complaint resolution systems for productivity and compliance.
Delivering Strategic Benefits
The second half of the framework emphasizes impactful and cohesive value delivery. It promotes service model transformation through centralized and consolidated operations, and supports digital transformation via automation. A dedicated ecosystem enables tailored solution development, and development centers ensure scalability. Strategic partnerships focus on critical success factors, CAPA implementation, and proven success stories with measurable outcomes.
Enabling Levers
Underpinning the E.P.I.C framework are enablers such as throughput management, process improvement, operation centralization, and software migration. These are reinforced by regulatory watchout and a culture of innovation, ensuring the complaints management process remains agile, compliant, and future-ready, turning compliance into a competitive advantage.
Why Tata Elxsi?
- Delivering exceptional customer value through comprehensive medical device complaint handling service and product-centric knowledge, ensuring alignment with customer needs.
- Utilizing in-house RPA-based accelerators and partnering with leading cloud-based telephony systems to significantly reduce infrastructure and hardware costs.
- Implementing Tata Elxsi’s rigorous governance and quality frameworks, with executive-level transparency and performance reporting.
- Over 200 vigilance experts and 20,000+ processed complaints, offering specialized knowledge across various therapeutic and product classes.
- Cost-efficient global delivery locations, scalable solutions, and diverse delivery models, optimizing costs by up to 40%.
In Focus
Information Hub
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How important is post-market surveillance for medical devices?
Post-market surveillance is vital for identifying real-world performance issues, ensuring ongoing device efficacy, and maintaining adherence to evolving standards like EU MDR. It involves collecting user feedback, analyzing adverse event reports, and updating risk assessments. Robust surveillance not only helps in early detection of quality gaps but also builds trust among healthcare providers, regulators, and patients, enabling devices to stay competitive and compliant.
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What is the importance of complaints handling in medical devices?
Effective medical device complaints handling is vital for patient safety and regulatory compliance. Complaints provide valuable feedback on real-world device performance, enabling prompt investigation, root-cause analysis, and corrective action. An efficient complaints management system aligned with ISO 13485 and MDR/FDA requirements not only mitigates risks but also improves product quality and strengthens customer confidence, ensuring manufacturers meet stringent post-market surveillance obligations and support a culture of continuous improvement.
