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: Apply Machine Learning to PLM with Product Lifecycle Intelligence: A Medical Device Use Case

How can medical device manufacturers leverage insights from PLM data to remain competitive? Here's the story of one manufacturer and how they drove measurable business results with machine learning.

Article: How PLI Can Decrease the Cost of Quality and Compliance

Early adopters of PLM have achieved valuable benefits to the product development process. However, PLM alone can no longer help.

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.

Article: Implementing IoT to Comply with GDPR: Five key transition benefits to increase ease of compliance with regulation EU 2016/679

The GDPR creates a standard methodology for data protection and establishes rights for individuals whose data is used in any way for any business purpose. Any company operating in the EU or selling products into the EU will need to comply. Here’s how the Internet of Things (IoT) can help.