Verification & Validation
Ensure product quality and compliance with Tata Elxsi's comprehensive Verification & Validation services, designed to meet evolving regulatory standards.
Introduction
Amidst the relentless competition in the MedTech industry, manufacturers are developing optimized test strategies, leveraging automation and DevOps to accelerate time-to-market. Comprehensive and rigorous Verification & Validation plans are being implemented to address the ever-changing regulatory requirements set forth by the authorities.
Furthermore, to enable better clinical outcomes, manufacturers are developing holistic solutions by integrating digital and novel technologies into their products. Moreover, enabling a seamless user experience across the value chain demands an additional emphasis on tests such as compatibility testing, security testing, etc.
Business Challenge
Product complexity, dynamic regulatory requirements, and rising quality expectations make traditional testing approaches inadequate. Organizations struggle to ensure compliance, reduce risk, and accelerate product launch without a structured, efficient V&V process. Delays in defect detection and lack of traceability often result in compliance gaps, product recalls, and increased time-to-market.
Here’s How We Help
In a highly regulated and competitive industry, the key challenge for the manufacturers is to ensure product quality, reliability, and patient safety throughout the medical device lifecycle.
While an early launch of a medical device in the market could lead to significant market share and maximum ROI, manufacturers with ineffective testing strategies go through prolonged testing cycles. This may also potentially lead to product recalls high cost of maintenance and dwindling customer confidence. To achieve product commercialization goals, companies are finding ways to accelerate product development through automation-based optimized V&V programs.
Service Framework
Our service framework encompasses the entire V&V lifecycle, ensuring a structured approach from initial requirement analysis to final reporting and certification, thereby guaranteeing product reliability and compliance.
Features
Comprehensive Test Coverage
Conduct functional, performance, compatibility, and security testing to identify and mitigate potential issues.
Risk-Based Testing Approach
Prioritize testing efforts based on risk assessment to focus on critical components and functionalities.
Continuous Integration and Testing
Integrate V&V processes into the development pipeline to detect defects early and streamline product releases.
Why Tata Elxsi?
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15+ years of safety-critical device V&V experience
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ISO 13485 certified facilities with QMS aligned to meet ISO 14971, IEC 62366, IEC 62304, 21 CFR part 820, and EU regulations
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Team of industry-trained biomedical and systems engineers with medium to high-risk device testing experience
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Technical documentation expertise catering to regulatory requirements in major and emerging markets
Information Hub
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How does Tata Elxsi ensure compliance with dynamic regulations?
We implement rigorous testing and validation processes aligned with current regulatory standards, ensuring that products consistently meet compliance requirements.
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What infrastructure does Tata Elxsi offer for remote testing?
Our extensive test labs and infrastructure include signal generators, spectrum analyzers, call generators, and packet analyzers, supporting comprehensive offshore and remote testing capabilities.
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What industries benefit from Tata Elxsi's Verification & Validation services?
We cater to various sectors, including healthcare, automotive, aerospace, and consumer electronics, ensuring product quality and compliance across diverse domains.
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What role does automation play in Tata Elxsi's V&V services?
Our in-house developed automation tools provide frameworks to design test plans, execute complex test cases through scripts, and generate reports, thereby enhancing efficiency and accuracy in the testing process.
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How does Tata Elxsi's V&V services reduce time-to-market?
By leveraging process-driven solutions and in-house automation tools, we minimize test cycles, enhance efficiency, and expedite product launches.
