Welcome to our Publications page! Discover our latest articles, research papers, and reports, offering in-depth insights and expert analysis on various topics. Stay informed with cutting-edge research and industry trends. Explore our collection and keep up-to-date with the latest developments.
Understand the essential role of PMS in ensuring compliance with MDR 2017/745 and its impact on medical device safety and regulation.
Discover the key differences between MDR 2017/745 and ISO 13485 in quality management for medical devices.
Discover how ISO 14971 plays a crucial role in medical device risk management and ensures success in product design.
Learn how to conduct Biological Evaluations for Medical Devices using ISO 10993. Follow essential guidelines to ensure safety and compliance.
Explore best practices for Clinical Evaluation for SaMD under MDR 2017/745 to streamline the process and ensure compliance.
MDSAP in Canada is key to your medical device’s success, ensuring compliance, smooth market entry, and adherence to regulatory standards.
Discover a step-by-step guide to FDA medical devices approval, outlining the process, requirements, and key considerations for manufacturers.
Toxicological risk assessment in medical devices plays an important role in ensuring safety and evaluating potential hazards.
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