Moving from Paper to Electronic Records: Hardwiring Compliance into Product Development

Medical device manufacturers face the same intense competition that other manufacturers face, but with the added burden of having to plan, develop, test and produce in an environment rigidly controlled by regulatory requirements. To meet regulatory mandates, medical device manufacturers must be able to provide, upon request, documentation supporting the entire product lifecycle, from concept through execution. For many companies, this means maintaining hardcopy records of all related product information. And with a paper-based system of record-keeping, this requirement adds a huge burden to an already formidable task. With an electronic system of record-keeping, medical device manufacturers could ease this burden by streamlining processes and automating record-keeping. By using an electronic system that both links Product Development and Quality System Regulations, and automates the task of capturing records, companies can focus on innovating, accelerating time-to-market, and improving their audit results. This white paper describes how you can ‘hardwire’ compliance into your product development processes with a validated system that automatically captures required records for regulatory purposes. In addition, you’ll learn how such a system improves performance of several critical business processes including regulatory compliance, quality systems management, detailed design, change management and requirements management. Lastly, you’ll get an overview of PTC’s Product Development System, which helps leading medical device manufacturers to automate compliance and gain a competitive advantage. Whi te Paper Medical Devices Page 2 of 8