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 PTC 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.

PTC 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:

Pre-configuration of PTC Windchill PLM software using best practices

Best practice overviews with story boards, demo scripts, and sample data for use in training and adoption

Web-based training of best practice processes that are modular by process, supporting phased deployments

Validation packages that are modular by process and include:

Computer System Validation Plan

System Requirements Specification (SRS)

IQ, OQ, and PQ Protocols

Validation Test Scripts

Requirements to Test Traceability Matrix

Software Validation Summary Report

Cloud onboarding processes for rapid cloud deployment

On-premise onboarding processes for companies that choose in-house deployments.