Value-Ready and Compliant PLM for the Medical Device Industry




Product Lifecycle Management (PLM) solutions boast many capabilities: document and design control, corrective and preventive action (CAPA), and risk, reliability, and nonconformance management. One such industry that can benefit from these capabilities is the medical device industry which has stringent controls on the quality of products manufactured. In 2011, the FDA proposed the “Case for Quality” program to ensure that medical device manufacturers are meeting the highest levels of device quality and safety throughout a product’s design, manufacture, and service. As medical devices become more advanced, they must be carefully controlled throughout the product lifecycle to ensure that they are meeting these strict industry regulations and standards. All aspects of a device must be looked at: from mechanical and electrical to software and hardware.

However, it can often take months for an organization to fully implement the solution and begin realizing the value of a PLM solution. For organizations that want to rapidly see results, a Value Ready Deployment (VRD) solution may be the right choice. 

Earlier today, PTC announced that it would bring the Smart and Connected capabilities of the Internet of Things (IoT) to the medical device industry with its Medical Device Industry VRD. The VRD offering is a set of pre-configured best practice processes deployed in PTC’s PLM solution, 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, 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. 

The PTC Medical Device Industry VRD is fully compliant with the FDA “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
  • Unique device identification (UDI)

To ensure that the solution meets the stringent regulatory requirements unique to the medical device industry, PTC is collaborating with USDM Life Sciences, the leading global professional services firm for life science and healthcare organizations. Our USDM collaboration plays an important role with respect to PTC’s PLM solution offering for the medical device industry. Together with the USDM solution, the PTC solution enables medical device industry customers to accelerate and streamline the validation process, allowing them to reduce the Cost of Poor Quality (CoPQ), improve compliance with government regulatory requirements, and improve new product introduction (NPI) cycles and performance. 

PTC’s Medical Device Industry VRD supports USDM’s Validation Accelerator Pack for Windchill – a complete set of validation document templates that can significantly reduce validation time and cost, as well as provide for faster implementation time and better system performance. This will assist in the software’s compliance with FDA regulations for the design and development of safe, effective medical devices. 

Click here to learn more about PTC’s Medical Device Industry VRD and be sure to join PTC at LiveWorx in Boston, MA USA on June 8th for a special break-out session, “Meeting FDA Standards for Medical Device Quality: An Out-of-the-Box Approach”. I look forward to meeting you there!