醫療器材數位主線
醫療器械合規性
透過整合和協作的數位框架，有效平衡醫療技術的品質和合規性。追蹤產品和流程的所有品質數據，確保品質數據的連續性並提高利害關係人的透明度。
如何更快實現醫療器材合規性？
為您的團隊提供數位工具，整合公司所有部門的品質數據，以持續掌握和監控法規遵循和程序。部署整合的品質和合規性數位框架，確保營運效率並建立資訊透明度。
徹底改變您的醫療器材合規流程
確保品質和合規性同步。實施整合數位系統、全面的醫療器材品質管理系統 (QMS) 和直覺的監管資訊管理系統 (RIMS)，以提高產品品質並改善與當局的互動。
的先進公司使用 PLM
多家領先公司已實施產品生命週期管理 (PLM) 系統一年多，以支援其數位轉型計畫。（生命週期見解）
節省文書工作
透過消除文書工作並利用電子設備歷史記錄 (eDHR)，將品質控制流程時間縮短 85%。(W.L.戈爾公司）
減少時間
透過資訊管理系統實現完全可追溯性，節省搜尋資料的時間。(iThera Medical)
創造創新且合規的醫療設備
了解閉環品質和合規解決方案如何使醫療科技產業受益。在敏捷的流程中提高合規性、提高品質並簡化監管流程，並透過全面、最新的結果讓您高枕無憂。
探索這三個關鍵路徑以了解更多資訊。
Utilize digital tools that centralize quality data from all company departments to continuously master and monitor compliance with regulations and procedures.
- Track quality and compliance data with an integrated digital backbone
- Automate the flow of documents and data to provide benefits over traditional paper processes including international access
- Coordinate multi-disciplinary teams and establish metrics to measure the effectiveness of quality processes
Identify potential problems early in the design and process development stages and reduce risk with a comprehensive Quality Management System (QMS) that ensures full traceability from design development to post-market surveillance.
- Address quality continuously with a comprehensive management system
- Leverage integrated Risk & Requirements management, Failure Modes and Effects Analysis (FMEA) and quality planning
- Ensure a complete Design History File (DHF) and Device Master Record (DMR) for seamless design transfer to production
Manage regulatory interactions throughout the product lifecycle and develop a quality-based culture.
- Improve interactions with health authorities via an intuitive information management system
- Make all required information available with a centralized and customized regulatory information management system (RIMS) powered by integrated data management
- Streamline processes such as preparing and submitting product registrations and handling adverse events reporting
伊瑟拉醫療
Boosting engineering information management efficiency reduces time spent hunting for data by over 65 percent
iThera Medical
Medical devices & pharmaceuticals
Munich, Germany
Polarion
使用 Polarion ALM，我們能夠為審核員提供嚴格、可靠的技術文檔，並具有完全的可搜尋性和可追溯性。由於所有所需資訊均經過審計證明，審計已在線上成功完成。
