focusing on software development processes and lifecycle management. IEC 62304, for example, emphasizes the importance of managing software risks and maintaining traceability throughout the software lifecycle, making it an essential standard for managing cybersecurity risks in medical devices. ...
For example, if you have single incidents of complaints or nonconformances, these may trigger a change in your documentation, labeling, product, design or specifications. Change management is your way of documenting what is changing. Perhaps the whole incident can be handled this way and there i...
a CAPA process is often at one extreme or another. Either CAPA is overused or it is underused. For example, imagine you receive a complaint on one of your medical devices. Or maybe you have a nonconformance. Does this singular event warrant issuing a CAPA investigation?
This is not a comprehensive guide on corrective action and preventive action (CAPA) for a specific industry like a medical device, pharma, etc., but a simplified overview of CAPA, with an example of various industries. Always follow the standards applicable to you and your company! What is C...
AssurX integrates with other business applicationsto provide greater insight and collaboration (for example, in CAPA investigations). Connect with MES, LIMS, ERP, CRM, and others to integrate your applications under a single CAPA software. This allows you to engage with other business areas seamless...
For example, the information included for Complaints #19-324-01 and #20-196-01 reasonably suggests that your firm’s device fractured. These fractures were noted after device explant. Per the Preamble, in the Medical Devices; Medical User Facility and Manufacturer Reporting, Certification and Regis...
effective. For example ISO13485 Medical Devices �C Quality Management Systems �C Requirements for regulatory purposes, Japanese Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and in vitro Diagnostics (MHLW1 Ministerial Ordinance No. 169), the FDA...
For example: a.具体来说,在2016年6月,贵公司启动了299677 CAPA (b)(4)#,以解决MiniMed 600系列胰岛素输液泵中固位环(透明固位环)损坏投诉增加的问题。企业的调查确定设备故障是由xx固定环引起的,而xx固定环又导致了xx。损坏的固定环可能导致胰岛素的过量或不足,从而可能导致低血糖或高血糖。从2019年8月开始...
(QMS). (If you want to know what I think is No. 1, shoot me an.) As you build medical devices, a well-defined CAPA program provides a framework for quality and effectiveness, whether in product, process, or people. That’s why getting the CAPA quality fundamentals right is...
AssurX integrates with other business applicationsto provide greater insight and collaboration (for example, in CAPA investigations). Connect with MES, LIMS, ERP, CRM, and others to integrate your applications under a single CAPA software. This allows you to engage with other business areas seamless...