英國IDC已成功過渡至ISO 13485:2016

新質量體系的成功過渡

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

IDC榮幸地宣佈，IDC質量體系完全遵從並已成功過渡至ISO13485:2016.

項目總監Brian Gough與設計工程師共同促進創新

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.”

項目總監Brian Gough表示：審計表上零不良記錄，對於IDC是莫大的榮譽，也顯示了IDC質量流程發展至今達到的深度。

提供獨一無二的質量保證

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認證包含於IDC整個組織構架，包括英國產品設計工作室、原型製作與小批量產車間及位於上海的中國分公司。

IDC整體組織構架都符合ISO 13485:2016認證

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.

與部分單純聚焦設計工作的諮詢機構不同，在產品從設計階段轉移至原型製作及投產階段的過程中，IDC在全流程各階段都能符合最嚴苛的質量要求。

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

正因如此，IDC能夠提供獨一無二的質量保證。

醫療產品研發的基石

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

安全與質量是醫療產品研發的基石。

歷經40餘年實踐，IDC設計研發流程在醫療產品開發項目中被不斷驗證其成功性

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.

對於產品全生命週期各階段的監管要求正逐漸變得嚴苛，其中即包含了質量與服務。在IDC建成至今的46年時間中，我們創建了一個分析型設計流程，並不斷被證明其成功性，尤其在醫療領域。此流程能夠使團隊甄別出諸多風險並就所有潛在挑戰給出回應，綜合考慮所有階段的監管要素並引導客戶，以確保客戶的商業成功。

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，提供了更深層次的保障，也強調了IDC未來對最佳實踐的承諾。