NEEDHAM, MA – June 6, 2016 –– PTC (NASDAQ: PTC) today announced the availability of its Medical Device Industry Value-Ready Deployment™ (VRD). This offering is a set of pre-configured, out-of-the-box best practices to help medical device companies build in product and process quality using the PTC Windchill® product lifecycle management (PLM) solution. PTC has partnered with USDM Life Sciences, a leading global professional services firm for life science and healthcare organizations, to enable its integrated and comprehensive PLM solution for medical device companies to address the stringent regulatory requirements unique to the industry.
“Our USDM collaboration plays an important role with respect to PTC’s PLM solution offering for the medical device industry,” said Swapan Jha, vice president, PLM, PTC. “Together with the USDM solution, the PTC solution enables medical device industry customers to accelerate and streamline the validation process, allowing them to reduce Cost of Poor Quality (CoPQ), improve compliance with government regulatory requirements, and improve new product introduction (NPI) cycles and performance.”
USDM’s Validation Accelerator Packs (VAPs) for PLM platforms, including Windchill, are a complete set of validation document templates that enable customers to significantly reduce validation time and cost, as well as reduce implementation time and improve system performance. PTC’s Medical Device Industry VRD supports USDM’s Validation Accelerator Pack for PTC Windchill to assist customers in validating the PTC solution’s compliance with FDA regulations for the design and development of safe and effective medical devices. This solution enables customers to improve patient safety and product efficacy while following the ISO 13485 standard, harmonized with the FDA Total Product Life Cycle (TPLC) and 21 CFR Part 820 regulations.
“Our VAPs are all about simplifying processes and providing value for our customers. Our newest VAP for PTC Windchill satisfies a growing demand to be able to quickly and efficiently validate this innovative and robust PLM solution,” said Kim Hutchings, vice president, Alliances, USDM Life Sciences.
Windchill 11, PTC’s smart, connected PLM solution, supports the FDA’s “Case for Quality” initiative by providing industry-leading capabilities for document control, nonconformance management, customer experience management (CEM), corrective and preventive action (CAPA), risk and reliability management, audit management, design control, and unique device identification (UDI).
The PTC Medical Device VRD enables medical device manufacturing companies to quickly realize the business benefits of PLM with proactive, high-quality, well-controlled, compliant, and traceable product development processes. This solution can be deployed in the Cloud as a SaaS-based offering; and, with little to no configuration required, it is also a great solution for small and medium-sized companies.
PTC’s Medical Device Industry VRD package includes the following key components:
If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easier to accelerate innovation and maximize productivity. We focus only on regulated industries and have built trusted partnerships with the best companies in the world, and boast a staff of industry leading experts in the areas of technology & compliance.
Our ability to explore and utilize the latest trends in technology while charting a map for our clients to remain compliant is a key differentiator in an industry mired with regulatory shackles.
When your operations and systems are compliant, data is current and accessible from anywhere, and people able to collaborate instantly, your organization becomes better and faster, the USDM way.