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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.

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