Regulatory approvals and faster compliance cycles with less effort
A PLM-enabled digital thread creates a consolidated “closed-loop” lifecycle system by combining regulators, manufacturers, and connected product-related data (Internet of Medical Things), resulting in end-to-end traceability.
With a fully integrated digital thread, medical device companies can avoid delays due to audits. Legacy systems and file cabinets that contain partial information can be retired. Instead, stakeholders are fully connected to the current state of the product throughout the entire lifecycle, streamlining change management and regulatory submissions.
Windchill, the industry-leading PLM software from PTC, provides the foundation and continuity of product and quality information across the digital thread, whether delivered on-premises or SaaS. With a validation-ready cloud, medical device companies and their design/manufacturing partners can take advantage of enterprise and multi-enterprise secure collaboration. Plus, Windchill’s out-of-the-box pre-configured ISO 13485 processes can be implemented quickly.
"With our long-standing commitment to provide continuous improvements that create quality that delights our customers, we needed a solution provider with a comprehensive offering, a scalable architecture, and a commitment to the medical device market—and we found all of that in PTC."