Meeting FDA Standards for Medical Device Quality: An Out-of-the-Box Approach
In the design and development of safe, effective medical devices, the FDA’s “case for quality” calls for manufacturers to ensure the highest levels of device quality and safety throughout product design, manufacture and service. It is no longer adequate to rely on inspections and citations alone. Device manufactures are now encouraged to take an independent, predictive, and proactive approach to ensure that products are manufactured to quality and safety standards for patients. In order to switch from a reactive to proactive mindset, manufacturers must be willing to invest in new technology to reduce the overall cost of poor quality. This session described PTC’s Medical Device Industry Value-Ready Deployment™ (VRD) offering and highlight Stryker’s case for quality and business case, which showcases Partners Kalypso and USDM Life Sciences, and industry leading best practices to deploy an out-of-the-box approach. Attendees to this session learned how PTC and Partners, Kalypso and USDM Life Sciences, can support your harmonized product development efforts to emphasize quality and compliance, engage stakeholders and ensure transparency of data while continuing to produce highly innovative products. More About the Value-Ready Deployment™: The VRD is a set of pre-configured best practice processes deployed in PTC Windchill to build in product and process quality. It maximizes patient safety and efficacy while following the ISO 13485 standard, harmonized with the FDA TPLC and 21 CFR Part 820 regulation. The VRD includes pre-defined configurations, training materials, getting started guides and a validation accelerator package. The VRD is designed to get medical device manufacturing companies up and running quickly with proactive high-quality, well-controlled, fully compliant and traceable product development processes.