Jim James

Founder EASTWEST PR and Host of The UnNoticed Entrepreneur.

ROSTI GROUP MALAYSIA ACHIEVES ISO13485 FOR MEDICAL DEVICE MANUFACTURE

ISO certification extends plastic moulding capabilities deeper into the medical sector. SINGAPORE: 09.12.2021 Rosti Group, the European headquartered technology led plastic moulding company and contract manufacturer, has achieved ISO13485 in the Malaysia plant. Meeting the stringent requirements of the International Organization for Standards for a quality management system will expand …

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罗斯蒂马来西亚工厂通过了医疗器械制造ISO13485体系认证

ISO13485认证将罗斯蒂马来西亚的注塑能力深入到医疗领域 中国,北京:2021年12月09日 总部位于欧洲的技术领先高精密注塑制造公司及合同制造商罗斯蒂集团在马来西亚的工厂通过了ISO13485体系认证。满足国际标准组织对质量管理体系的严格要求,在医疗器械样件制造方面提供72小时“从概念创意到产品实现”的服务能力,并延申至医疗器械的全面生产。罗斯蒂团队克服了疫情带来的困难和挑战,确保工厂能够及时通过认证,以全面支持医疗器械生产。 这座占地5000平方米的工厂是罗斯蒂集团继中国、罗马尼亚和波兰的工厂之后获得ISO13485认证的第4家工厂,它为医疗领域的客户提供多样的服务,从原型制造到大规模生产的灵活的整体解决方案。除了注塑、移印、装配、工艺开发、模具和供应链管理之外,该工厂还拥有生产和验证复杂产品的专业度。集团参与了某高科技生物公司COVID-19唾液检测试剂盒的开发和生产,可以在15分钟内获得与临床检测同等效应的结果。根据Precedence Research的数据,2019年全球医疗器械市场规模为4476.3亿美元,预计到2027年将达到6714.9亿美元。 罗斯蒂马来西亚的团队 罗斯蒂马来西亚总经理Miller Brown说到:“团队共同努力,维护和不断改进系统以获得ISO13485认证,这是我们取得成功的关键因素。有助于我们与客户一起开发新的医疗器械项目并协助其第一时间完成产品上市。他说:“疫情期间我们遇到了许多挑战,但员工获得该体系的决心充分体现了大家为罗斯蒂马来西亚的未来不断努力奋斗。” 位于柔佛州的罗斯蒂马来西亚拥有约90名员工,在罗斯蒂集团的“中国+1”战略中发挥着关键作用。集团在全球拥有8家工厂,3个数字创新实验室(中国、波兰、美国)。通过ISO13485认证是罗斯蒂马来西亚的一项重要投资,未来马来西亚工厂还将投资建立独立的医疗生产车间,使用专业的医疗注塑机,确保设施设备具备生产医疗器械的全部追溯性。 拥有ISO13485认证的设施设备及运营能力,为医疗器械市场生产产品和部件,提供了与现有客户建立更多合作的机会,并开辟了在生命科学领域发展的机会。除此以外,罗斯蒂马来西亚还通过了ISO9001、ISO14001、ISO45001体系认证以及UL认证。 关于罗斯蒂集团 罗斯蒂集团于1944年成立,总部位于瑞典马尔默,在欧洲和亚洲拥有8家制造工厂,拥有约3200名员工。罗斯蒂隶属于价值120亿美元的瑞典投资集团Nordstjernan。公司致力于塑料产品的开发和生产。罗斯蒂现已发展成为国际领先的高精密注塑制造商,也是包装、医疗、消费电子、工业和商用机器等行业的世界领先品牌首选合作伙伴。 罗斯蒂秉承“从概念创意到产品实现”的理念,为客户提供更好的组件、产品、流程和一站式解决方案。想要了解更多信息,请访问www.rosti.com或在LinkedIn上关注我们。 The post 罗斯蒂马来西亚工厂通过了医疗器械制造ISO13485体系认证 appeared first on EASTWEST Public Relations.

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‘Drinking and Knowing Things’: The story and unique spirit of sommelier Michael Juergens

By Jim James, Founder EASTWEST PR and Host of The UnNoticed Entrepreneur.  Michael Juergens is a Certified Sommelier who has written a book titled “Drinking and Knowing Things.” He also has a company called Bhutan Wine Company. As an entrepreneur and a bestselling author, he was featured in the latest …

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With the Mobibi app, you can mobilise your whole team to get your business noticed

By Jim James, Founder EASTWEST PR and Host of The UnNoticed Entrepreneur.  Matthew Stormoen’s company called Mobibi has created a crowdsourcing-type of content system or platform to help entrepreneurs get noticed. They use technology to empower your employees to create content, share important company news, and, more importantly, be engaged …

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Find out how this app can turn your employees into the biggest ambassadors for your company.

To empower your entire organization to post to the social media accounts of the business is to lighten the load of the marketing manager, or entrepreneur, and also generate massive engagement within the team; plus more interesting content!We discuss how employee advocacy can turn  employees into the biggest ambassadors and …

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INEOS Outlines Its Plans For Selling And Servicing The Grenadier Worldwide

In a recent media briefing to Singapore and Taiwan media, INEOS Automotive is striking agreements with retail and aftersales partners around the world to establish up to 200 sales and service points for the July 2022 launch of the Grenadier 4X4.  The comprehensive service network means most customers will never be further …

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