Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

VP and CISO for Mandiant, helping guide the company's product and solutions strategy and host of the Cyber Security Effectiveness Podcast. Understanding the effectiveness of your company's security ...

Bryan Ennis is the CEO and cofounder of Sware, a regulatory technology company serving healthcare, life sciences and SaMD companies. “The measure of intelligence is the ability to change.” This famous ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global enterprises operating under the scrutiny of the FDA, EMA, and other regulatory ...