CAPA is a critical requirement in the regulatory frameworks governing medical devices. For instance, ISO 13485:2016 mandates implementing a CAPA process to manage quality issues throughout a device’s lifecycle. CAPA plays a pivotal role in ensuring compliance with regulatory bodies like the FDA, em...
CAPA process definition is a huge issue for medical device companies. If you recall, this issue is the single biggest reason that the FDA has issued hundreds of 483 observations to medical device companies every year since 2010. These instances are usually the result of one of three things: T...
ISO 13485: This is an international standard that specifies requirements for a quality management system. An Organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It has specific sections dedicated...
Food and Drug Administration (FDA) to Ohio Medical, a manufacturer of intermittent suction units, regarding its failure to initiate a corrective and preventive action (CAPA) for complaints received for its medical devices. The CAPA problems were discovered during a recent inspection of Ohio Medical ...
(68) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market; “现场安全纠正措施”是指制造商出于技术或医疗原因采取的纠正措施,以防...
3.贵公司未能在收到或以其他方式获悉合理表明已上市器械可能导致或增加死亡风险或严重伤害的信息后30个日历天内向FDA提交报告,符合21 CFR 803.50(a)(1)的要求。 For example, the information included for complaint #CASE-2020-00236012 describes an event in which your firm’s MiniMed Insulin Pump malfunction...
在本函和检查结束时发布的FDA 483检查意见中指出的具体违规行为可能是贵公司生产和质量管理体系存在严重问题。贵公司应调查并确定违规原因,并立即采取行动纠正违规行为,使产品符合要求。 Sincerely, /S/ Shari J. Shambaugh Program Division Director Office of Medical Devices and Radiological Health, Division...
EU Medical Device Regulation ISO 9001 Quality Management Systems CGMP Regulations for Combination Products EU IVDR EU In-Vitro Diagnostics Regulation CASE STUDY How Highline Warren, a $1B manufacturing organization, went from a paper & pencil CAPA system software to digital with AssurX. ...
Mastering CAPA management is part of the proactive quality mindset that regulators demand, but it is also an absolute requirement for achieving commercial success in the medical device industry. Requirements for CAPA management as they apply to the highly regulated world of medical device development ...
They don’t escalate issues to CAPA when the issues warrant it. This runs the risk of FDA warning letters and undue delays with maintaining safe and effective products on the market. With these pointed out, it’s important for medical device companies to be able to distinguish whether an iss...