7 Benefits of Risk Management in Medical Device Production
Risk management in medical device production is a systematic, dynamic, continuous, and multifaceted process. In this highly competitive medical device landscape, implementing risk management strategies is not only about compliance but also a necessity. Manufacturers...
12 Common Pitfalls in Medical Device Regulatory Submissions
We have discussed some of the common mistakes in medical device regulatory submissions. Understanding these common pitfalls will help streamline your application and improve your chance of approval. Additionally, we have provided some tips for avoiding these...
9 Key Differences Between Clinical Study and Clinical Evaluation of Medical Device
Clinical study and clinical evaluation of medical devices are common regulatory requirements for market approval. These terms are often used interchangeably. However, they have different purposes, are used in different situations, and have different protocols. Hence,...