새로운 프로그램을 위한 혁신적이며, 협업이 가능한 동기화된 프로그램 관리
Complexity in the development of medical devices, especially for smart medical devices that include software and electronics, demands software solutions to establish design controls that orchestrate the design process across inter-disciplinary engineering teams.
Intelligent Design Control is our solution for medical device companies to become data-driven, model-based, and document smart. Intelligent Design Control increases engineering efficiency and speed across the device lifecycle while avoiding costly errors, quality issues, and recalls.
Complexity in the development of medical devices, especially for smart medical devices that include software and electronics, demands software solutions to establish design controls that orchestrate the design process across inter-disciplinary engineering teams.
Intelligent Design Control is our solution for medical device companies to become data-driven, model-based, and document smart. Intelligent Design Control increases engineering efficiency and speed across the device lifecycle while avoiding costly errors, quality issues, and recalls.
The development of modern, complex medical devices is a big challenge, especially for smart medical devices which increasingly use software and electronics to deliver essential therapeutic and diagnostic capabilities. Establishing regulatory-mandated design controls by tracking and tracing the network of user needs, risks, design requirements, and verification and validation testing can become overwhelming without the use of software-based solutions.
The risk of incomplete, incorrect data can lead to errors, quality issues, loss of time, poor performance, and significantly increase the likelihood of recalls. Intelligent Design Control is our holistic solution for integrating requirements and risk management, test planning and execution, and design output management, including Design History Files (DHF) and Device Master Records (DMR).
Enable your medical device company to become data-driven and document smart by powering your design process across mechanical, electrical, and software engineering teams with increased speed and clarity to produce safe high-quality device designs. Furthermore, our smart solution supports devices throughout the entire lifecycle by re-using data and connecting it via digital threads to quickly respond to inquiries during regulatory reviews or sustaining incremental engineering changes.
Explore the key areas of this solution.
Enable companies to efficiently synchronize all data, domains and functional areas, including secure supplier collaboration. Provide a scalable, best-in-class platform for integrating outputs from all engineering disciplines.
Avoid copy mistakes, ensure the integrity of data, manage medical device records and provide traceability across entire device lifecycle.
Material information and how it’s managed can have a profound effect on your product’s lifecycle, and materials data management often plays a role in the success of the product.
Teamcenter 내 SDPD(시스템 기반 제품 개발) 솔루션이 멀티 도메인 제품 개발(기계, 전기 및 소프트웨어)과 비용, 신뢰성 및 제조 가능성 등의 고려 사항을 모두 지원합니다.
요구 사항의 가치는 파악하는 데 있는 것이 아니라 제품 개발 프로세스를 주도하는 데에 있습니다. Teamcenter는 다양한 다운스트림 기능/형상/제품 아키텍처에 요구 사항을 할당하며, 이 모두는 보고서, 문서 및 대시보드를 생성하여 요구 사항 프로세스를 관리하는 동안 이루어집니다. Microsoft Word 및 Excel을 포함한 비슷한 Microsoft Office 애플리케이션에서 직접 요구 사항을 생성, 보기 및 편집할 수 있습니다. 라이프사이클 통합 요구 사항을 통해 전체 제품 라이프사이클에서 "통합을 시작하고 유지"한 개발 프로세스를 지원할 수 있습니다.
CAE 및 시스템 시뮬레이션을 효율적으로 관리하고 모든 의사결정권자가 제품 성능을 더 잘 이해할 수 있도록 공유하여 보다 확실하고 빠르게 혁신을 제공합니다.
Effectively gather, author, approve and manage requirements for complex systems across the entire medical device lifecycle.
테스트 프로세스 개선 및 생산성과 제품 혁신 강화
Close the loop on device requirements by capturing and associating verification and validation results while also enabling focused testing. Our closed loop processes ensure requirements are directly tied to how devices are verified and validated.
요구 사항의 가치는 파악하는 데 있는 것이 아니라 제품 개발 프로세스를 주도하는 데에 있습니다. Teamcenter는 다양한 다운스트림 기능/형상/제품 아키텍처에 요구 사항을 할당하며, 이 모두는 보고서, 문서 및 대시보드를 생성하여 요구 사항 프로세스를 관리하는 동안 이루어집니다. Microsoft Word 및 Excel을 포함한 비슷한 Microsoft Office 애플리케이션에서 직접 요구 사항을 생성, 보기 및 편집할 수 있습니다. 라이프사이클 통합 요구 사항을 통해 전체 제품 라이프사이클에서 "통합을 시작하고 유지"한 개발 프로세스를 지원할 수 있습니다.
증가하는 복잡성과 규제 감독이 어떻게 의료 기기 개발을 어렵게 만드는 지에 대해 알아보십시오. 설계 제어가 경쟁력을 제공하는 중요하고 포괄적인 솔루션인 이유에 대해 알아보십시오.
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