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Transitioning to enterprise quality management system (eQMS) software may seem overwhelming for medical device companies at first, especially if they are coming from a paper-based system. We asked Arena’s Customer Success Coach Gay Groce to tell us about her background and share some insights on how companies can best utilize the Arena QMS platform for their product development processes and...
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....