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#2 - 5 key questions every medical device manufacturer should ask Top articles from 2020: A product-centric QMS approach supports continuous improvement, streamlines regulatory compliance, and simplifies validation. ) doesn’t prescribe how to produce a specific device, but states manufacturers “should use good judgment when developing their quality system and apply those sections of the QSR that apply to their products and operations.” It’s the manufacturer’s responsibility to establish the appropriate methods and procedures to design, produce, distribute, and deliver devices meeti...

#1 - 2020 forecast: Growth and outsourcing Top articles from 2020: An aging and growing population combined with increasing healthcare spending supports medtech’s continuing growth Healthcare spending will grow to $6 trillion annually, an average of 5.5% compound annual growth rate (CAGR) to 2027, according to The Centers for Medicare and Medicaid Services. That growth continues boosting demand for medical devices. Valued at $425.5 billion in 2018, the global medical device market is forecast to reach $612.7 billion by 2025, registering a 5.4% CAGR. A growing global medical device market le...