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Reduce Time to Clearance

Reduce Time to Clearance

Ensuring regulatory compliance is critical when defining and executing processes for Design and Document Control, building DHF and DMR structures, and authoring submissions for clearance. Delays, manpower and costs can impair any medical device manufacturer faced with audit or compliance concerns. 

Our Reduce Time-to-Clearance solutions provide precise and predicable response rates when facing complex issues and rapid change. Through digitalized data organized in logical structures, information can be used and reused accurately and effectively.

Ensuring regulatory compliance is critical when defining and executing processes for Design and Document Control, building DHF and DMR structures, and authoring submissions for clearance. Delays, manpower and costs can impair any medical device manufacturer faced with audit or compliance concerns. 

Our Reduce Time-to-Clearance solutions provide precise and predicable response rates when facing complex issues and rapid change. Through digitalized data organized in logical structures, information can be used and reused accurately and effectively.

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Achieving timely and predictable regulatory clearance for submissions is a primary objective for medical device companies. Delays lead to changes in business plans, missed opportunities for revenue growth, and increased R&D costs.

A key to achieving clearance is excellence in design control business processes, including related processes for DHF, DMR and document control. Without systemic support for these processes, it is impossible to adapt to correct problems during development, prior to submission. The inability to respond to an audit or evidentiary request as part of a regulatory review can be costly, consuming key resources for days, weeks or even months.

A digitalized approach to these processes is the core of our Reduce Time to Clearance solution. Enabling development projects for data-driven responses to complex issues is a proactive and predictable method for addressing inevitable problems and changes. Our solutions help companies construct digital twins and utilize digital threads that digitize device information into structures that lead to better decision making and reuse when addressing errors and change management.

Funcionalidades de la solución

Design Output Management

Our Design Output Management solutions for medical device manufacturers provide med-tech engineering teams with a solid and integrated approach to lifecycle management where all requisite data is housed within a single, efficient environment

Intelligent Design Control

Our Intelligent Design Control solution helps medical device companies become data-driven, model-based, and document smart by increasing engineering efficiency and speed across the device lifecycle while avoiding costly errors, quality issues, and recalls.

Manufacturing Execution System

Complete visibility, control, and optimization of production and processes across the enterprise.

Quality Operations Management

Ensure end-to-end quality management across your manufacturing process. Focus on prevention to streamline compliance and reduce the cost of quality.

Resource & Allocation

Siemens PLM Software’s digital manufacturing software capabilities for shipyard production combine a range of 3D visualization, simulation, planning and supporting data management applications.

Software Change & Configuration Management

Systematically control change to maintain software integrity and traceability throughout the software development lifecycle.

Software Issue & Defect Management

Track all possible and reported failures. Plan and assign tasks to mitigate risk.

Software Requirements Management

Effectively gather, author, approve and manage requirements for complex systems across the entire project lifecycle.

Software Test & Quality

Design, coordinate, and track all your test management activities in a single, collaborative QA environment.

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