Medical Device Regulations & Compliance
行业观点
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![审计合规性法规ISTOCK-1161029738]( "MDSAP Audit Approach Updated From Rev. 6 To 7")
MDSAP审核方法从Rev. 6更新到72022年4月15日，MDSAP审核方法AU P0002.007从006版本更新到007。本文总结了对医疗设备制造商了解的重要更改。
欧洲通知的身体反馈表明，在临床证据中，尤其是在临床性能数据周围，发现了2017/746（IVDR）的体外诊断医疗设备法规的最大差距。本文还涵盖了欧盟和FDA要求之间重叠的讨论。
The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).
Amid continuing focus on environmental, social, and governance (ESG) priorities among investors across every industry, medtech companies need to begin revisiting business models and developing new sustainability strategies for competitive edge as well as regulatory compliance.
欧盟的医疗设备调节是指多次利益风险比率，尤其是在临床评估以及附件I的第1和8节中。但是，没有普遍接受的方法来计算这种比率。本文提出了一种以专注于患者安全性以及跟踪产品安全概况变化的能力来计算它的方法。
WHITE PAPERS & CASE STUDIES
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![检查]( "The Search For Control: Total Quality In Life Sciences")
The Search For Control: Total Quality In Life Sciences将数据带入一个地方，以在研究，开发和制造的每个阶段获得端到端的可见性和可追溯性。188bet软件下载苹果
培训定义了您组织中最重要的资产的质量：您的员工。良好的培训管理过程是针对质量差的预防措施。
医疗设备制造是一个复杂的行业，188bet软件下载苹果因此确定每个公司要数字化的领域可能很困难和不同。在这里，我们探讨了医疗设备和诊断制造商正在拥抱数字工具，以最大程度地提高数据的价值，因为该行业从危机模式到进化。
The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.
在医疗设备开发中，文档控制过程的速度，效率和准确性是重中之重。监管机构正在拥抱进步技术，以有效地实现确保公共卫生和安全的使命，包括与文档直接相关的增强。
ABOUT MEDICAL DEVICE REGULATIONS & COMPLIANCE
根据1976年的《医疗设备法规法》，美国食品药品监督管理局（FDA）在美国对医疗设备（从构想到发出后评估）以及随后对1938年《联邦食品，药物和化妆品法》的修正案进行了监管。
FDA的医疗设备监管途径（用于上市审查，清除和批准）是基于三个分类的，这表明确保设备的安全性和有效性所需的监管控制程度。I类设备被认为是低风险的，许多设备免于监管过程。II类设备需要特别控制“标签，指导，跟踪，设计，绩效标准和后市场监控”，并且大多数需要上市通知510（k），以证明与法律上具有相同的等价性（具有相同的预期使用和技术特征）市场设备。III类设备通常维持或支持寿命，植入或呈现出疾病或伤害的重大风险。大多数III级设备都需要预批准（PMA），该设备检查了权衡设备的预期使用与可能风险的预期使用可能的健康益处的各种因素。
医疗设备制造商必须遵守当前良好的制造实践（CGMP）法规，FDA检查员用来确定制造商是否具有生产和包188bet软件下载苹果装产品的设施，技能和设备。此外，FDA要求所有医疗设备都携带机器和人类都可以读取的唯一设备标识符（UDI），以“改善患者安全，现代化设备后市场监视并促进医疗设备创新”。
Medical device makers competing in international markets must monitor and adhere to the policies of foreign regulatory bodies, which can vary greatly, depending on the nation. Further, many global regulators require manufacturers to be certified by the International Organization for Standardization (ISO). ISO 13485 compliance, confirmed through third-party (Notified Body) audits, demonstrates a medical device manufacturer’s procedures and products meet or exceed international quality standards.
Efforts are also underway to standardize international regulations to ensure the safety, effectiveness, and quality of medical devices. The International Medical Device Regulators Forum (IMDRF) — composed of regulatory agencies from Australia, Brazil, Canada, China, Europe, Japan, Russia, and the United States — is building upon previous work by the Global Harmonization Task Force on Medical Devices (GHTF) to speed this harmonization and convergence.
最新的头条新闻
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Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark2/15/2018
Edwards Lifesciences Corporation（NYSE：EW）是针对患者心脏病和重症监测监测的患者创新的全球领导者，最近宣布，它因其自我膨胀的中心瓣膜而获得了CE Mark，该中心是严重的，有症状的主动脉st虫患者的高风险开心手术。
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Arterys’ Oncology Imaging Suite With Deep Learning Cleared By FDA2/15/2018
Arterys Inc., the leader in intelligent, cloud-based medical imaging software solutions, recently announced its fifth 510(k) clearance from the U.S. Food and Drug Administration (FDA).
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拥抱成为第一个FDA清理癫痫发作监测的智能手表2/5/2018
Empatica Inc has received clearance from the FDA for Embrace, its award-winning smart watch. Embrace uses AI (advanced machine learning) to monitor for the most dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures, and send an alert to summon caregivers' help.
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FDA清除了Zimmer Biomet的总肩关节置换术系统1/3/2018
Zimmer Biomet Holdings，Inc。（NYSE和SIX：ZBH）是肌肉骨骼医疗保健的全球领导者对于患有骨关节炎，创伤后关节炎，肱骨头局灶性血管坏死或以前没有肩部手术的患者，患有骨关节炎，创伤后关节炎，局灶性血管坏死。
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K2M的3D打印的可扩展造型笼带有颈椎指示获得CE标记12/20/2017
K2M Group Holdings, Inc.(NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it received a CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage System* featuring Lamellar 3D Titanium Technology™, and the successful completion of its first surgical case.
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便第一个无线雷达乳腺肿瘤定位System For Long-Term Implant Cleared By FDA11/13/2017
Cianna Medical，Inc。已获得FDA清除长期植入物的SaviScout®反射器。萨维侦察兵反射器是用于无线乳腺肿瘤定位的侦察系统的组成部分。
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CardioFocus’ HeartLight Excalibur Balloon For AF Treatment Earns CE Mark10/27/2017
CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF).
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Acutus Medical’s Real-Time Cardiac Mapping Systems Cleared By FDA2017年10月24日
AcutusMedical®今天宣布，美国食品药品监督管理局已清除ACQMAP®高分辨率成像和映射系统以及ACQMAP®3D成像和映射导管，用于用于开处方电生理程序的患者。
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FDA清除Game Ready的多模式恢复设备2017年10月6日
The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elite™.