{"id":10933,"date":"2026-08-06T14:04:31","date_gmt":"2026-08-06T14:04:31","guid":{"rendered":"https:\/\/www.sanner-group.com\/%e7%bd%91%e7%bb%9c%e7%a0%94%e8%ae%a8%e4%bc%9a\/"},"modified":"2026-09-22T10:20:33","modified_gmt":"2026-09-22T10:20:33","slug":"%e7%bd%91%e7%bb%9c%e7%a0%94%e8%ae%a8%e4%bc%9a","status":"publish","type":"page","link":"https:\/\/www.sanner-group.com\/zh-hans\/%E6%B4%9E%E5%AF%9F\/%E7%BD%91%E7%BB%9C%E7%A0%94%E8%AE%A8%E4%BC%9A\/","title":{"rendered":"\u7f51\u7edc\u7814\u8ba8\u4f1a"},"content":{"rendered":"
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8th 10 \u6708 2026<\/p>\n \n

\n Decoding FDA SaMD Guidance: Risk Stratification Beyond Traditional Device Classes<\/a>\n <\/h3>\n\n

Michael Marks, Systems Engineer at Sanner, will walk you through how the IMDRF framework works, why it exists alongside rather than in place of traditional device classification, and how risk category should inform design controls, verification and validation, and QMS integration.<\/p>\n \n

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12th 11 \u6708 2026<\/p>\n \n

\n Bridging the Gap: A Guide to Medical Device Design Transfer<\/a>\n <\/h3>\n\n

Design transfer is where many promising medical devices lose time and budget, as a design that works in development meets the realities of scalable, repeatable manufacturing. In this webinar, Megan Conley and Nick Smartt walk through how to plan for transfer early, align engineering and manufacturing teams, and build the documentation and process controls that carry a device smoothly from prototype to production.<\/p>\n \n

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7th 12 \u6708 2026<\/p>\n \n

\n Streamlining 510(k) Approval for CE-marked MDR Devices<\/a>\n <\/h3>\n\n

Many manufacturers with CE-marked devices under the EU MDR assume their technical documentation will carry over directly to FDA, only to find gaps in predicate selection, testing expectations, and submission format that slow their path to the US market. In this webinar, Jim Fentress explains how to leverage your existing MDR documentation, identify where FDA requirements differ, and build a 510(k) strategy that reduces rework and shortens time to approval.<\/p>\n \n

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17th 9 \u6708 2026<\/p>\n \n

\n Transforming User Research into Products that People Use, Trust, & Love<\/a>\n <\/h3>\n\n

Explore how Human Factors activities shape early medical device development and drive smarter Industrial Design. We will explain the Industrial Design process and how user needs are translated into actionable design requirements and priorities.<\/p>\n \n

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29th 12 \u6708 2025<\/p>\n \n

\n Use related risk analysis & how it applies to medical device development<\/a>\n <\/h3>\n\n

As the landscape of medical device regulations continues to evolve, it\u2019s crucial to stay ahead of the curve when it comes to Use-Related Risk Analysis (URRA). This webinar is designed to equip professionals with the knowledge needed to identify, assess, and mitigate use-related risks effectively.<\/p>\n \n

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10th 12 \u6708 2025<\/p>\n \n

\n Maximizing Value From Design Controls<\/a>\n <\/h3>\n\n

In the highly regulated world of medical devices, design controls are not just a mandatory step in your go-to-market journey; they are pivotal in driving product quality and safety. This webinar goes beyond the basics to provide a comprehensive deep dive into design controls, tailored to the unique challenges faced by premarket medical device companies.<\/p>\n \n

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12th 11 \u6708 2025<\/p>\n \n

\n The Importance of Human Factors in Medical Device Development<\/a>\n <\/h3>\n\n

Grant Leffingwell, Head of Human Factors at Sanner America and Marcus Agunloye, Head of Human Factors at Sanner UK talk you through why Human Factors are critical in medical device development, when and how to apply Human Factors during your design process, and tools and activities to strengthen your Human Factors approach.<\/p>\n \n

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3rd 9 \u6708 2025<\/p>\n \n

\n Building Smarter Devices with Integrated Systems<\/a>\n <\/h3>\n\n

In this webinar we explore how integrating electromechanical technologies into your devices can lead to smarter, more responsive solutions that drive better patient outcomes.<\/p>\n \n

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1st 9 \u6708 2026<\/p>\n \n

\n Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment<\/a>\n <\/h3>\n\n \n
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