ISO 13485:2016
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ISO 13485认证:它是什么?
安全和质量对医疗器械行业至关重要, 这就是为什么建立ISO 13485认证的质量管理体系是确保这些设备正确开发的关键. ISO is the International Standardization Organization which defines the requirements for quality management systems specific to various critical industries. The ISO 13485 medical device certification regulations have become the standard of Quality System regulation for the FDA and its international equivalents, 专注于基于风险的产品开发方法.
While many 产品开发 companies operate to ISO 13485 certification standards for medical devices and 软件, 并非所有企业都拥有自己的ISO 13485认证质量管理体系. Obtaining ISO 13485 medical device certification for the Quality Management System requires rigorous internal audits by an independent third party. 他们的调查检查了公司的整个运作程序, 确保从仪器校准到文件命名的一切工作, 是密封的. Successful completion of audits show that a company’s practices are completely oriented to ensure their designs meet FDA standards of documentation.
甘露加工过程中的质量保证
甘露开发的产品必须值得信赖，以改善，有时甚至挽救，病人的生命. 因此，产品的创造必须经过精细的调整, requiring tedious and detailed assessment; an ISO 13485 certified QMS is proven to support this undertaking.
对于Nectar来说，获得ISO 13485认证不仅仅是持有这个高质量的证书. Our medical device quality assurance has been woven into our DNA as regulatory compliance standards can be found through each step of our proven process. 从研究到验证, Nectar’s quality engineers track and record every single variable to ensure our medical devices and products are safe and reliable.
为我们的pg电子游戏哪个平台好和消费者, our ISO 13485 medical device certification and quality assurance system can assure that your medical devices and 软件 systems are achieving the most prestigious standards possible in the global market.
达伦是一位多才多艺、充满活力的领导者，他创立了Nectar、X-Naut和BreathDirect. 他致力于通过技术、科学和艺术的综合来改善世界. 在达伦的领导下, Nectar is leveraging the latest advances in cutting-edge technology to transform medical device development and design. 作为他的
Dr. Steve Wells在指导Nectar的运营和确定其战略方向方面发挥着关键作用. 他卓有成效的领导为公司的成功开辟了一条清晰的道路. He has revitalized the company with a passion for maximizing impact through expert resource utilization since taking the helm in 2020. 史蒂夫提升了甘露的pg电子游戏哪个平台好, 简化流程, 并重振其创新议程, 所有这些都是为了开发挽救生命和有影响力的产品. 他在乔治菲舍尔担任高级领导职务的背景和他以人为本的思想, 以结果为导向的领导风格使他成为我们pg电子游戏哪个平台好的宝贵财富. 史蒂夫丰富的化学知识, 生物相容性, 生物学只会增加他作为pg电子游戏哪个平台好成员的价值.
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