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Focus on designing and delivering life-changing MedTech products. Leave gaps and disconnects in the past. Move forward with design control management that keeps innovation, quality, and traceability at the forefront.
Using paper-based solutions and disconnected systems to achieve traceability is expensive and time-consuming. Ensuring visibility and connectivity between inputs, outputs, verifications, and validations is not an easy feat. Your QMS should drive collaboration for design actions, link documents, conduct project reviews, and generate a design history file — all with a single click.
Designed specifically for MedTech professionals with simplicity and flexibility in mind.
Enable product development teams to leverage the agile functionality of Jira while maintaining traceability to Design Controls processes throughout the MedTech lifecycle.
Industry standards require that stand-alone software components be managed separately, just like the hardware and software components of traditional medical devices. Manage both your software components and devices through their own design workflow to ensure that each component is reviewed and approved as part of the whole product.
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