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  • 导航欧洲MedTech法规的新景观

    The EU’s Medical Device Regulation (MDR, effective May 26, 2021) and the In Vitro Diagnostics Regulation (IVDR, effective in May 2022) are certainly hurdles for medical device manufacturers to tackle. However, those aren’t the only new regulations in Europe to prepare for.

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    As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. Jayet Moon, author of the book Foundations of Quality Risk Management, takes a bottom-up approach to PMS with this e-book.

  • Risk Based Approaches To Establishing Sample Sizes For Process Validation
    Risk Based Approaches To Establishing Sample Sizes For Process Validation

    该电子书是对各种基于统计的技术的汇编,以帮助确定基于风险的样本量以支持流程验证活动。流程验证是FDA发出的最常见的483个检查观察之一。引用通常表明该组织未能“确保无法通过随后的检查和测试对过程的结果进行充分验证时,该过程应具有高度的保证并根据既定程序进行批准”(21 CFR 820.75 -过程验证)。

  • 识别和解决组织内的错误,缺陷和问题


  • 19_10_MDO_DrugDeliveryEbook_450X300

    是否你想哄一个蹒跚学步的扭角羚g cough medicine or puzzling out how best to introduce a large-molecule biologic, each drug delivery scenario presents unique challenges. Teams developing the drug must work hand-in-hand with teams developing the delivery device, ultimately agreeing on the proper combination of elements to best serve the intended patient pool — a process that weaves together decisions concerning biocompatibility, container size and shape, delivery mechanism, human factors engineering, and countless other elements. In this eBook, our editors have assembled insights from some of the experts in this field among our editorial contributors.

  • 19_09_MDO_DataIntegrityEbook_450x300

    This eBook is a collection of articles from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.

  • 19_09_mdocybersecurityeebook_450x300

    3D印刷每天都在建立对生命科学行业的关键。用于创建解剖学精确的手术准备模型,制作假肢和Medtech原型,甚至证明其盐是大量生产组件的可行选择,该技术的上限是无限的。在这本电子书中,在线Med Device Online在我们的编辑贡献者中收集了来自该领域的一些专家的见解。

  • 19_09_mdoddcomboductebook_450x300

    药物输送设备和组合产品日常发展 - 比以往任何时候都更加紧凑,更便携,更适合用户友好,更健壮,更适合各种患者人群。在这本电子书中,Med Device Online在我们的社论贡献者中收集了该领域的一些专家的智慧。

  • 19_09_mdo_3dprintingebook_450x300
    3D Printing and Prototyping in Medical Device

    3D印刷每天都在建立对生命科学行业的关键。用于创建解剖学精确的手术准备模型,制作假肢和Medtech原型,甚至证明其盐是大量生产组件的可行选择,该技术的上限是无限的。在这本电子书中,Med Device Online在我们的编辑贡献者中收集了来自该领域的一些专家的见解。

  • MDO_RegulatoryEbook_300x200

    What is our readers’ greatest shared concern? Demystifying the constantly evolving regulatory landscape each medical device must navigate before it can help patients. Learn more in thisfree collection of articles强调监管混乱如何耗时,昂贵和对您的品牌造成破坏。