Arena Blog

Topic: ISO

The FDA’s Adoption of ISO 13485: What Medical Device Manufacturers Should Know

IntroductionAs globalization of medical device supply chains has continued to increase, regulatory bodies have grappled with how to bridge the gap between domestic and foreign regulation. Without a unified approach to both, the daily practice of ensuring that regulatory processes are followed and properly documented is even more challenging. The announcement that the FDA plans to use ISO 13485 as the basis for its quality system legislation signals an important ...

Dec. 19, 2018

Three Quality Subsystem Improvements That Streamline FDA Compliance

IntroductionMaintaining readiness for FDA inspections can be arduous and time-consuming, and the need for preparedness is growing. While the FDA continues to issue more observations than Form 483s, the number of observations has been decreasing, while the count of Form 483s has been increasing. A renewed focus on the quality subsystems that are most frequently cited with issues in Form 483 inspections can streamline FDA compliance and inspection readiness. Here ...

Dec. 10, 2018