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.

Products & Services

EU MDR Compliance | EU IVDR Compliance | Clinical/Performance Evaluation Report Consulting & Writing | Post Market Surveillance | Medical Device Packaging & Labeling | TEDREG - A Global Regulatory Intelligence Platform

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.

The Road Ahead

Latest Techology, Partnership and Media updates

Discover More

Impact of EU IVDR on Key Compliance Areas
Blog

Impact of EU IVDR on Key Compliance Areas

Automating Regulatory Intelligence for the $10 Trillion Global Healthcare Market
Business Whitepaper

Automating Regulatory Intelligence for the $10 Trillion Global Healthcare Market

Combination Products: FDA guidance on the Principles of Premarket  Pathways
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Combination Products: FDA guidance on the Principles of Premarket Pathways

EU IVDR Compliance: Challenges Faced by the Manufacturers and the Role of a Remediation Partner
Technical Whitepaper

EU IVDR Compliance: Challenges Faced by the Manufacturers and the Role of a Remediation Partner

5 Ways to Transform Post Market Surveillance using Artificial Intelligence
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5 Ways to Transform Post Market Surveillance using Artificial Intelligence

Decoding the New European Union In-Vitro Diagnostics (IVD) Medical Device Regulation 2017/746
Technical Whitepaper

Decoding the New European Union In-Vitro Diagnostics (IVD) Medical Device Regulation 2017/746

Global Regulatory Requirements and Manufacturers Responsibilities for Medical Device Vigilance Reporting
Whitepaper

Global Regulatory Requirements and Manufacturers Responsibilities for Medical Device Vigilance Reporting

5 Emerging Markets for Medical Device Manufacturers
Business Whitepaper

5 Emerging Markets for Medical Device Manufacturers

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