future-diagnostics产品代理
future-diagnostics产品代理
任何检测开发的认证合作伙伴。
无论您需要高度专业的知识还是人力来将您的概念推向市场，我们都是您值得信赖的独立合作伙伴，可使用不同的手动或自动技术开发多种不同类型的免疫测定。我们通过了 ISO 13485 认证，并拥有自己的 FDA 注册制造工厂，提供中小型试点和商业生产能力。免疫分析、即时 (POC) 测试或验证服务 - 您可以期待卓越的性能。
IVD产品开发-IVD产品开发流程-未来诊断
成熟的开发方法：质量、合规性和透明度
为确保最高质量、合规性和透明度，我们将经过验证的新产品开发流程应用于所有检测开发。自然地，EN 13612:2002 和 EN ISO 23640:2015 要求和适用的 CLSI 指南都包含在此过程中，就像编写 IVD 注册所需的技术文件的一部分一样。在整个项目过程中，我们的专业专家团队将定期让您参与其中，您还可以在 SharePoint 中实时监控进度。
更多技能、更多速度、更多成功
供应链全球化、成本和上市时间压力越来越大，以及客户对质量的期望越来越高，这些都是企业面临的挑战。要在当今的 IVD 医疗器械市场保持领先地位，您需要一个能够迎接挑战的专业合作伙伴。我们拥有技能、经验和动力来帮助您快速成功地将您的检测方法推向市场。
We are the obvious choice for in vitro diagnostic (IVD) assay development – for start-ups, mid-sized biotech companies and multinationals in the global IVD medical device market. With 20+ years of expert experience and 150 IVD developments, our 70+ enthusiastic and highly skilled professionals are committed to accelerating healthcare innovation, providing high-quality assay development and
manufacturing services.
Certified partner for any assay development.
Whether you need highly specialized knowledge or manpower to bring your concept to market, we are your trusted independent partner for the development of many different types of immunoassays, with different technologies, either manually or automated. We are ISO 13485 certified and boast our own FDA registered manufacturing facility, offering small to medium scale pilot and commercial production capabilities. Immunoassays, point-of- care (POC) tests or validation services – you can expect superior performance.
IVD product development - IVD product development process - Future Diagnostics
Proven development approach: quality, conformity and transparency
To ensure highest quality, conformity and transparency, we apply our proven New Product Development Process to all assay development. Naturally, EN 13612:2002 and EN ISO 23640:2015 requirements and applicable CLSI guidelines are incorporated in this process, as is writing part of the technical file you need for IVD registration. Throughout the project, our dedicated expert team will involve you on a regular basis, and you can also monitor progress real-time – in SharePoint.
More skills, more speed, more success
Supply chain globalization, increasing pressure on costs and time to market, and ever-higher quality expectations by customers are challenges that companies face. To stay ahead in today’s IVD medical device market you need a specialized partner that is up for the challenge. We have the skills, the experience and the drive to help you deliver your assay to market rapidly and successfully.
