Can Medical Device Manufacturers Speed Innovation and Lower Costs while Increasing Quality?

Medical device manufacturers have consistently focused on bringing innovative products to market. To achieve this, most companies have implemented sequential design and manufacturing processes to ensure the regulatory compliance and the highest possible quality. But sequential processes have become inadequate and CDRH is advocating the Total Product Life Cycle.

TPLC provides a strong foundation for managing every stage of a product's lifecycle more effectively, as well as across product platforms and succeeding generations. Executing a TPLC approach would result in accelerated time-to-market at lower costs and higher quality. Regulatory compliance would be a natural outcome of that improved and well-documented lifecycle collaboration process.

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Designing a Winning CAPA System

CAPA is a critical Quality System subsystem that, when executed correctly, can provide your organization with a clear payback in terms of improved compliance, effectiveness and operational efficiency. So what is required of a CAPA system to make it compliant, effective and efficient in the United States, Europe, Canada or Japan?

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