At Kiwa Assurance, we recognize that innovation is a constant in the medical device industry. But change comes with responsibility—especially when it comes to maintaining compliance under the MDR and ISO 13485. That’s where our Notification of Change (NoC) process plays a vital role.
Under the European Union's medical device regulations, MDR (EU 2017/745) and IVDR (EU 2017/746), it has become mandatory for all devices to be included in a common classification system. This classification system is defined as the European Medical Device Nomenclature (EMDN) and plays a critical role in the placing of devices on the market, traceability and technical file content.
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.
Join us in celebrating World Standards Day on October 14! Explore how international standards shape a safer, more sustainable world and see how Kiwa is contributing to global progress through our commitment to the Sustainable Development Goals (SDGs). Discover more about our role in building a better future.
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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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