The Importance of ISO 14971 in Medical Device Risk Management
June 1, 2025
Discover how ISO 14971 plays a crucial role in medical device risk management and ensures success in product design.
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
Discover how ISO 14971 plays a crucial role in medical device risk management and ensures success in product design.
Discover the key differences between MDR 2017/745 and ISO 13485 in quality management for medical devices.
Understand the essential role of PMS in ensuring compliance with MDR 2017/745 and its impact on medical device safety and regulation.
Key changes for your biocompatibility strategy.
A practical guide to understand the 2025 update and what it means for your medical device documentation.
Understand how ANVISA’s RDC No. 1,030/2026 may impact cosmetic formulations, product portfolios, and regulatory compliance deadlines in Brazil.
Anvisa advances its Regulatory Sandbox initiative for personalized cosmetics while global regulators strengthen post-market surveillance.
Learn more about the FDA’s regulatory framework for AI-powered medical devices and other global recent updates.
In the development and approval process of medical devices, three types of evaluations frequently appear in regulatory requirements: biological evaluation,
In addition to the MDR/IVDR review, unique device identification codes in China were given a final deadline. Learn more.
Alternatives for cosmetic animal testing advance with new FDA guidance and other global updates.
Learn how cosmetic registration works in the main global markets, including the U.S., EU, and Brazil, and plan a safe
Understand the concept of regulatory reliance and how initiatives from IMDRF, FDA, and Anvisa are impacting global regulation.
The UK regulatory authority opens a consultation on CE mark recognition and highlights other key global regulatory updates.
Discover how ISO 14971 plays a crucial role in medical device risk management and ensures success in product design.
Discover the key differences between MDR 2017/745 and ISO 13485 in quality management for medical devices.
Understand the essential role of PMS in ensuring compliance with MDR 2017/745 and its impact on medical device safety and regulation.
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