News: What is MDSAP? Malaysia Joins the Program
October 10, 2025
Malaysia joins MDSAP, expanding global audits. Plus: FDA software guidance, IMDRF PCCP guideline, and Anvisa’s new import process.
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
Malaysia joins MDSAP, expanding global audits. Plus: FDA software guidance, IMDRF PCCP guideline, and Anvisa’s new import process.
Proven steps for Quality Control Medical Devices and how a robust QMS aligned with ISO 13485:2016 can help you meet FDA compliance.
Explore the essential steps and best practices for conducting an internal audit of medical devices. Ensure compliance with expert tips!
Toxicological risk assessment in medical devices plays an important role in ensuring safety and evaluating potential hazards.
Discover a step-by-step guide to FDA medical devices approval, outlining the process, requirements, and key considerations for manufacturers.
MDSAP in Canada is key to your medical device’s success, ensuring compliance, smooth market entry, and adherence to regulatory standards.
Explore best practices for Clinical Evaluation for SaMD under MDR 2017/745 to streamline the process and ensure compliance.
Learn how to conduct Biological Evaluations for Medical Devices using ISO 10993. Follow essential guidelines to ensure safety and compliance.
Key changes for your biocompatibility strategy.
A practical guide to understand the 2025 update and what it means for your medical device documentation.
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