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Closed-Loop CAPA: What Is the Big Deal?

Closed-Loop CAPA: What Is the Big Deal?

If my phone locks up today and I can’t pay for my skinny mocha latte at Starbucks without pulling out crumpled bills and coins, it costs only my irritation and a slight delay in the line as the cashier and I struggle through an actual cash transaction. However, the failure of my hip implant (too much skiing?) would mean increased pain, possible poisoning, and possibly the eventual removal and...

How Scalable Is Your Supply Chain?

How Scalable Is Your Supply Chain?

Scaling Part II: Five tips for maintaining scalable supplier relationshipsThere are a variety of steps you can take internally to prepare your business to scale, but being truly ready means focusing on more than your…

Why Design Controls Are Good Business Sense for Any Product Company

Why Design Controls Are Good Business Sense for Any Product Company

Insights from Christopher Hill, Director of Regulatory and Quality Affairs, Organ Recovery Systems This blog is the final of our three-part series on design controls. The first explained why “Good Design Controls Are Critical to Avoid FDA Issues” and the second entailed Vis Ayer’s account of “How Nevro Achieved Design Controls Success. ” Here we encapsulate our discussion with Christopher Hill...