Medical - articles
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2 minA comprehensive overview of pre-clinical and clinical evaluation processes
In the dynamic realm of medical device development, the journey from conceptualization to market availability is intricate and demands meticulous evaluation at various stages. This text explains the processes of pre-clinical and clinical evaluations, essential components in ensuring the safety, performance, and regulatory compliance of medical devices.
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2 minImpact on medical device manufacturers under the MDR 2017/745/EU
The Medical Devices Regulation (MDR 2017/745/EU) is a significant step forward in aligning European Union legislation with technological advancements, advancements in medical science, and the evolution of legal frameworks. By understanding the MDR requirements, manufacturers can navigate the intricate landscape of compliance and contribute to safer and more effective medical devices in the European market.
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2 minAI Medical Device Software
Recently, the European Parliament adopted the Artificial Intelligence Act: MEPs adopt landmark law. The regulation aims to safeguard fundamental rights, democracy, and environmental sustainability. The new set of rules implies a need for more careful examination of the evidence regarding the continuous safety and performance of AI-driven medical device software.
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3 minThe new Medical Device Regulation: improving safety through expert auditing
From May 2021, new European rules for medical devices (MDR) will apply. The MDR has major impact on the medical sector. It will bring great benefit, but also great challenges for all economic operators involved.
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3 minPost-Market Surveillance: Key Considerations for Medical Device Compliance
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.
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2 minFacing the MDR: Kiwa races to help customers transition
Huge numbers of medical devices manufacturers will have to comply to the Medical Devices Regulation (MDR) by May 2024 to be able to market their products in Europe. Kiwa helps clients throughout Europe, and beyond, with this challenge.
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3 min
Navigating the impact of AI in Medical device certification: A comprehensive insight
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.
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3 minOur Commitment to Safer Diagnoses on World Patient Safety Day
How do we ensure safer healthcare diagnoses? On World Patient Safety Day 2024, discover Kiwa’s role in certifying diagnostic devices to meet the highest safety standards. Learn more from Yeşim Sekizelma, Lead Auditor at Kiwa Turkey.
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3 minUnlocking the benefits of ISO 13485:2016 for your organization
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.
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