Viewpoints By David Wolf

Article: Drive a Culture of Quality with Digital Quality Management

As the medical device industry shifts toward value-based healthcare, the traditional focus on compliance is not enough. Here are the benefits of closed loop digital quality management, and a three-phased approach to get there.

Article: Seven Leading Practices for Risk Management in Medical Device

Effectively managing risk in the medical device industry can be complex, but it’s increasingly important. Doing it well is often a key strategic differentiator, so we’ve outlined seven things that we’ve seen industry leaders do that set them apart.

Article: Leading Practices for EUDAMED and Basic UDI

Got questions about Basic UDI compliance? This article offers a technical deep-dive into the context, basics, and best practices to adapt to this new normal across the medical device industry.

Article: Streamlining your EU MDR Compliance Journey

The European medical device industry is undergoing a transformation as the new European Medical Device Regulation is set to come into effect. As companies rethink their current strategies amidst the evolving regulatory landscape, they’re able to take market share from competitors by becoming an EU MDR compliance pioneer. Those organizations that are non-compliant will be unable to participate in the EU market until they are certified.