When it comes to commercializing medical devices in the United States, manufacturers must manage many moving parts—from establishing quality management processes and effective design controls to preparing the necessary documentation and clinical evidence for FDA approval. The first step in obtaining FDA approval is classifying your medical device. This is a critical step, as it determines the...

Enterprise software integrations had a long history of being complex, requiring a lot of time and resources to implement. Companies wanted to integrate but were reluctant. Today, the need to integrate product lifecycle management (PLM), quality management system (QMS), enterprise resource planning (ERP), customer relationship management (CRM), and other enterprise solutions is just as strong,...

How do you drive innovative product development and stay ahead of the competition, while ensuring regulatory compliance? This is a common dilemma for most aerospace and defense companies, as they try to keep up with today’s ever-changing industry standards.We asked Arena’s Customer Success Coach Marshall Wood to tell us about his background and share some tips on how companies can best leverage...