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Understanding MDSSPRO compliance solutions for Medical Device Regulatory Compliance
Navigating the regulatory landscape for medical devices is complex. Regulations like MDR 2017/745 and standards such as ISO 13485 require thorough understanding and precise execution. I want to share insights on how MDSSPRO compliance solutions can help medical device manufacturers meet these challenges effectively. This post breaks down key aspects of regulatory compliance and practical steps to achieve certification and market access. Why MDSSPRO compliance solutions matter
Patricia Vest
3 days ago3 min read
Post-market surveillance (PMS)
Post-market surveillance (PMS) is a critical component of ensuring the safety and performance of UKCA-marked medical devices once they are available on the market. It involves monitoring, gathering, and analysing data on the device's performance to identify any issues or adverse events that may occur during real-world use. In the UK, PMS requirements for medical devices are aligned with the UK Medical Devices Regulations 2002, amended to reflect recent updates post-Brexit and
Patricia Vest
3 days ago1 min read
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