Medical Device Regulatory Compliance

Navigate complex and evolving regulatory landscape with confidence and certainty

The global regulatory landscape has dramatically evolved over the years to ensure a high degree of device efficacy and patient safety. As healthcare companies are adhering to the regulatory framework of the operating markets and continuously exploring new growth opportunities, managing the high volume of work while containing the cost of compliance has become the key to sustainable business.

Case Study

Driving QARA Programs through a Global Engineering Network

Products & Services

Quality Assurance and Regulatory Affairs (QARA)

Discover Tata Elxsi's comprehensive suite of Quality Assurance and Regulatory Affairs (QARA) services tailored to the medical device industry. From regulatory submissions and approvals to cutting-edge technology-driven solutions, we ensure compliance, patient safety, and global market access. Our expertise spans Quality Management Systems (QMS), risk management, process validation, and audit support.

EU MDR Compliance

Accelerate to meet EU MDR compliance efficiently and well before the deadline without restricting the program's critical-to-business growth. Tata Elxsi's outcome-based "Compliance Assurance Model" ensures EU MDR compliance certainty while its proprietary agile-based "ScrumDR methodology" overcomes the complexities of the transition process.

EU IVDR Compliance

Tata Elxsi addresses key concerns such as submission readiness for EU Notified Bodies, non-EU submissions, clinical data sufficiency, post-market surveillance, and performance evaluation with its proven agile-based "ScrumDR processes". Furthermore, Tata Elxsi's industry-first "Compliance Assurance" model brings catalog pricing and business outcomes-based execution to maximize confidence and minimize risk in EU IVDR transition programs.

Clinical and Performance Evaluation Report Consulting & Writing

Mitigate the impact of global regulatory changes on your clinical affairs function. Tata Elxsi's experience over the years, coupled with its repository of ready-to-use checklists and templates, allows it to deliver high-quality CER, SSCP, PSUR, PMCF reports, among others, across all safety classes and medical device specialties.

Post Market Surveillance

Tata Elxsi helps manufacturers minimize clinical risk exposure and detect/predict potential product failures in the field through effective complaints management program and proactive post-market oversight. Furthermore, Tata Elxsi ensures product sustenance in the market by efficiently identifying the need for preventive, corrective, or field safety action.

Medical Device Packaging & Labeling

Tata Elxsi helps manufacturers standardize and automate labeling workflow across multiple manufacturing sites, thus saving significant costs associated with the product launch, sustenance, rebranding, and recalls due to mislabeling. Tata Elxsi also supports the companies in designing & developing sterile packaging and aseptic presentation in compliance with ISO 11607-1 and ISO 11607-2.

TEDREG - A Global Regulatory Intelligence Platform

An intelligent platform built to aggregate and organize the latest regulatory updates from major regulatory bodies across the globe and provide actionable insights to the manufacturers for new market launches and product sustenance in the existing markets.

View all