新质量体系的成功过渡

IDC is delighted to announce it has transitioned to the medical device standard, ISO 13485:2016, seamlessly with conformity throughout the quality process.

IDC荣幸地宣布，IDC质量体系完全遵从并已成功过渡至ISO13485:2016.

项目总监Brian Gough与设计工程师共同促进创新

Projects Director, Brian Gough, comments, “It’s quite an accolade to achieve a completely clean sheet during auditing, with no non-conformities, and this goes to show just how far our quality processes have developed at IDC.”

项目总监Brian Gough表示：审计表上零不良记录，对于IDC是莫大的荣誉，也显示了IDC质量流程发展至今达到的深度。

提供独一无二的质量保证

The ISO 13485:2016 certification applies to the whole of IDC’s organisation, and includes its product design studio, prototyping and production unit in IDC Models, as well as IDC China in Shanghai.

ISO 13485:2016认证包含于IDC整个组织构架，包括英国产品设计工作室、原型制作与小批量产车间及位于上海的中国分公司。

IDC整体组织构架都符合ISO 13485:2016认证 

Unlike many consultancies who work purely on the design side, IDC is able to meet the toughest quality requirements at all stages of the design process, as the product moves through the development from design to prototyping and production.

与部分单纯聚焦设计工作的咨询机构不同，在产品从设计阶段转移至原型制作及投产阶段的过程中，IDC在全流程各阶段都能符合最严苛的质量要求。

As a result, IDC can provide a level of quality assurance that is unique amongst competitors.

正因如此，IDC能够提供独一无二的质量保证。

医疗产品研发的基石

Safety and quality are of paramount importance when developing medical products.

安全与质量是医疗产品研发的基石。

历经40余年实践，IDC设计研发流程在医疗产品开发项目中被不断验证其成功性

Regulatory requirements are also becoming increasingly stringent throughout every step of a product’s lifecycle, including quality and service. IDC has developed its own design process over the last 46 years and this analytical approach to design has proved highly successful, particularly for medical products. The process enables the team to identify risks and respond to any potential challenges, consider regulatory aspects at all stages and guide clients through the development to ensure commercial success for clients.

对于产品全生命周期各阶段的监管要求正逐渐变得严苛，其中即包含了质量与服务。在IDC建成至今的46年时间中，我们创建了一个分析型设计流程，并不断被证明其成功性，尤其在医疗领域。此流程能够使团队甄别出诸多风险并就所有潜在挑战给出回应，综合考虑所有阶段的监管要素并引导客户，以确保客户的商业成功。

ISO 13485:2016 in combination with ISO 13785:2016 and ISO 9001:2015 provides further assurance and highlights IDC’s commitment to best practice for the future. 

ISO 13485:2016融合了ISO 13785:2016 及 ISO 9001:2015，提供了更深层次的保障，也强调了IDC未来对最佳实践的承诺。