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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

Clinical/Performance Evaluation Report Consulting & Writing | Medical Device Packaging & Labeling | TEDREG - A Global Regulatory Intelligence Platform

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. 

Post-Mergers & Acquisitions (M&A) Integration

Elevate post-M&A performance with Tata Elxsi's QARA expertise. From post-acquisition due diligence to facilitating a seamless transition, we offer a suite of QARA solutions to help streamline workflows and foster innovation through ecosystem partnerships

PFAS Compliance​

Explore Tata Elxsi's specialized suite of Per- and Polyfluoroalkyl Substances (PFAS) compliance services, meticulously crafted for the medical device industry. From regulatory navigation to innovative solutions, we safeguard compliance, environmental responsibility, and market viability. Partner with us to navigate PFAS regulations seamlessly, ensuring product safety and regulatory adherence in a dynamic global landscape.​

Product 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.

Clinical 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.

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

Transforming Complaint Management for Enhanced Medical Device Performance
Case Study

Transforming Complaint Management for Enhanced Medical Device Performance

Deciphering the PFAS Regulations for Medical Device Manufacturers
Technical Whitepaper

Deciphering the PFAS Regulations for Medical Device Manufacturers

Transforming MedTech Operations and Device Quality through Design History File Compliance
Case Study

Transforming MedTech Operations and Device Quality through Design History File Compliance

EU MDR Remediation and Global Submission Support for Non-EU Countries
Case Study

EU MDR Remediation and Global Submission Support for Non-EU Countries

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
Blog

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
Blog

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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