“Manage end-to-end validation and verification processes, and gain holistic insight into product quality.”
— McKinsey, The Business Case for Medical Device Quality
For medical device manufacturers, ensuring patient safety is both a moral and financial imperative. Quality practices are mandatory. More importantly, they are integral to the successful delivery of medical innovation.
Many medical device manufacturers manage regulatory workflows using paper-based systems or disconnected, single-purpose software solutions. For these organizations, regulatory record-keeping amounts to an overhead activity that depletes time, money and resources.
PTC PLM products were built on the premise that product quality requires more than late-stage testing. Rather, it requires a whole team, whole lifecycle approach. We invented the world’s first Internet-based PLM solution – Windchill – partly in order to help customers govern lifecycle processes and achieve ISO 9001 certification.
From these quality-centric roots, PTC has extended its core Windchill product lilfecycle management capabilities into a suite of offerings designed to help medical device manufacturers streamline, simplify and gain greater value from their quality investments.
Stryker Endoscopy improves safety and streamlines regulatory reporting.
PTC’s Medical Device quality solutions deliver pre-configured, out-of-the-box best practices designed for life sciences companies. The solutions maximize patient safety and efficacy while following best practices for regulated life sciences environments, and are harmonized for ISO 13485, FDA TPLC and 21 CFR Part 820 regulations.
PTC quality management capabilities for medical device manufacturers includes:
Expertly manage all forms of digital product data – including mechanical, electrical and software
Provide a quality governance process for managing both internal and external audits
Manage the intake, evaluation, resolution and tracking of product and process nonconformance