Quality Management for Life Sciences

Achieve closed-loop quality for CAPA, nonconformance, complaints, document control, and other quality processes.

Quality is everyone's business

Failure to deliver products that perform as expected can result in regulatory action, loss of reputation, reduced market share, and patient harm. Yet key gaps remain. Studies show that fewer than 40% of medical device makers consistently close the loop on quality. Overcoming the quality gap requires fresh thinking and mastery of the following topics. Learn more about Windchilll Product Quality.

Prontas para uso: as soluções da PTC oferecem valor e adequação funcional imediatos

Os recursos da PTC incluem recursos de IoT predefinidos e completos para permitir processos "conectados" de design, fabricação e manutenção. Isso permite uma abordagem de implantação "sistemas de sistemas", comprovada com "desempenho anterior significativo" na área militar com base no modelo SCOR, bem como nas cadeias de suprimentos de muitos OEMs do Departamento de Defesa dos EUA, de companhias aéreas e de MROs.

Por exemplo, a solução de software SPM da PTC sincroniza fornecimento e demanda com a manutenção. Essa abordagem "sistemas de sistemas" resulta na máxima preparação para todos os ativos terrestres, aéreos ou marinhos.

Close the loop on quality

Explore the SaaS-based PLM and quality solution designed to make life easier for product quality professionals.

Get up-and-running quickly with best practice configurations for CAPA, complaint and nonconformance management
Improve first-time fix rates by tracing quality issues back to specific version-controlled parts and design documents
Leverage quality intelligence to continuously improve products and processes
Establish structured, controlled and repeatable quality processes
Accelerate new product introductions by qualifying for FDA trusted vendor status
Reduce the cost of managing quality throughout your product lifecycle

Explore Windchill Product Quality

"With our long-standing commitment to provide continuous improvements that create quality that delights our customers, we needed a solution provider with a comprehensive offering, a scalable architecture, and a commitment to the medical device market—and we found all of that in PTC."
Jayne Odom, VP Enterprise Portfolio Management, Terumo BCT

Get inspired

Quality activists never rest. Get valuable insights on rethinking or fine-tuning your product quality programs.

axendia report — Axendia 2018 Survey of Medical Device Innovators

White paper. “Despite significant advances in medical technology, when it comes to lifecycle quality processes, industry is still reactive.”

Fresenius: A Fresh Look at Product Quality

Webcast. “If I type the product name, you should be able to look at the requirements of the product, the components, complaints, CAPAs—the whole product DNA. This will help us become more proactive and less reactive.” - Sri Tupil, Vice President of Quality Engineering

dan matlis axendia — Axendia: Shifting From Compliance to Quality

Webcast. “Through a collaborative effort across the medical device industry, we are driving a culture shift. We are shifting the primary focus of the relationship from regulatory compliance to a state of sustained product quality.” - Dan Matlis, President, Axendia

How Researchers Are Preparing for EU-MDR

Webcast. “EU MDR compliance is a journey… Leaders are nearly twice as likely to prepare for EU-MDR by investing in new systems.” - Greg Cline, Research Analyst, Aberdeen

How Abbott Is Getting Its Digital House in Order: Getting Your Product Development Right for EU-MDR

Webcast. Hear from Caroline Byrd, Abbott Director of Regulatory Affairs and global EU-MDR program lead, on how Abbott is driving a sustainable compliance program that will not only comply, but fundamentally transform and improve core quality processes.