How do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality. PMS is a regulatory requirement in major markets like Europe and United States.
When done right, your PMS system can improve your device, provide better service to your users, and reduce the risk of adverse events before they happen. But with a myriad of regulatory obligations looming over you, implementing a PMS system can be overwhelming. What you will learn in this 6-page white paper:
We answer all of these questions and many more in this white paper.
Elizabeth Pugh: Elizabeth Pugh is a Regulatory Affairs Consultant at Emergo. She has over 15 years of experience with regulatory affairs in the medical devices industry, and previously held positions at Stryker, FoxHollow Technologies, and DJO Surgical. Her areas of expertise include CE Marking compliance, post-market surveillance, and global vigilance reporting.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多您的公司为符合欧盟医疗器械法规(MDR)作了哪些准备? 在MDR规定下,医疗器械CE认证要求发生了重大变化,因此,医疗器械公司应当清楚地了解其合规程度,以及他们仍需采取哪些措施才能确保遵守新法规并维持欧盟市场准入资格。 我们的欧盟MDR准备情况检查表可以帮助您评估您
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