Post-market surveillance (PMS) has undergone significant transformation under the Medical Device Regulation (MDR) in Europe. It marks a new era in the monitoring and reporting of medical device safety and performance. This set of requirements emphasizes the proactive collection and analysis of medical device-related data after a product is placed on the market, allowing manufacturers to reassess the safety and effectiveness of their medical devices continuously.
As AI technology takes flight, there's a growing urgency to investigate its influence on medical devices. In this article we will explore the complex world of AI-based medical devices, emphasizing the need for rigorous clinical evaluations and robust regulatory compliance.
By adhering to ISO 13485, organizations can establish a comprehensive quality management system that not only ensures regulatory compliance but also enhances overall performance and safety. Let's explore the manifold benefits this standard brings to your organization in the context of the medical device industry.
World Water Day 2023 focuses on accelerating progress towards universal access to safe water and sanitation. Kiwa, an independent third party, is developing innovative solutions to improve water efficiency, safeguard supply, ensure water quality and support waste treatment to work towards SDG 6. Take personal action and partner with organizations committed to sustainable development to solve the water and sanitation crisis.
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Artificial Intelligence (AI)-based software medical devices are revolutionizing the healthcare sector in diagnosis, treatment, and patient management. AI-powered Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) applications cover a wide range of solutions, from medical decision support systems to patient monitoring tools.
The rules for placing medical devices on the Great Britain (GB) and Northern Ireland (NI) markets differ primarily in terms of the timelines and regulatory frameworks
Registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates in Great Britain (GB) and Northern Ireland (NI).
To register medical devices with the MHRA, manufacturers must follow specific requirements and procedures. In this article you will find the key steps and requirements.
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