Healthcare - articles
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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 minBetter safe than sorry: patient safety on the digital highway
There is no sector in the world that handles so much personal data as the healthcare industry. Information security is therefore an important part of patient safety. ISO 27001 certification can help organizations with that.
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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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