Aerospace & Defense
Innovation and collaborative, synchronized program management for new programs
Ensuring regulatory compliance is critical when defining processes for DHF, DMR, and Design and Document Controls. 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.
Explore the key areas of this solution.
Capture and communicate requirements with an integrated platform for medical device organizations.
Manage risk across the entire lifecycle with requirements management.
Track user needs and design inputs and outputs. Trace verification and validation test plans and status.
Integrate and manage processes for device design outputs and data. Ensure accuracy and efficiency with a multidisciplinary approach and global scalability.
Oversee progress, manage risk, and resolve issues. Integrate change control processes with accurate data and procedures.
Create and manage quality medical device product documents, manuals and technical publications.
Manage and execute medical device design projects in a unified platform.
Model manufacturing processes digitally prior to production to improve manufacturability and reuse best practices.
Leverage accurate design and manufacturing information across the entire device lifecycle chain.
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.
Learn how our customers benefit from this solution.
"Reduce Time-to-Clearance" with our digitalized, data-driven procedures for medical device companies to ensure rapid, accurate and cost-effective response rates to complex compliance and regulatory concerns.