Category: Product Development

Artificial intelligence (AI) is reshaping how products are designed, built, and brought to market. From automating routine tasks to providing

Medical devices are becoming more complex, more connected, and increasingly used in home settings by people with varying levels of

If you missed our recent panel discussion, “From Concept to Compliance: Navigating Risk and Regulatory Submissions Across the Life Sciences,”

In the medical device industry, where precision and compliance are paramount, staying ahead of regulatory changes is critical. With FDA

How a risk-based design approach provides safer and ultimately better quality products to market. Product designs are stronger when risk

Medical device development is a complex process, with a critical element focusing on risk management. The consequences of not managing

An introduction to how smart data utilizes information and actionable context to support business-critical decisions. It may sound fanciful to

In the highly regulated world of medical device manufacturing, the relentless requirement to minimize and mitigate risk places a huge

Key takeaway: The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and

Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to