Compliance issues can create significant barriers for medical device companies looking to bring new products to market. In 2020 alone, the U.S. Food and Drug Administration (FDA) issued 422 citations or observations (i.e., Form 483) to medical device companies, indicating that their products were in potential violation of regulatory requirements1. These FDA observations typically stem from...

With Industry 4.0 ushering in a new era of technologies such as the Internet of Things (IoT), machine learning, and robotics, it’s no surprise that the adoption of cloud-based product lifecycle management (PLM) software continues to rise. To navigate the complexities of this technological era, companies are looking for more efficient and cost-effective ways to bring new products to market....

The medical device industry is in dire need of robust, practical, and easy-to-use software to make regulatory professionals’ lives easier. Without a unified and collaborative digital system for regulatory activities, serious consequences to a business can occur, including an increased risk of noncompliance, increased costs, and a significant reduction in a product’s revenue potential. Here are...