AssurX Blog
Straight talk for regulated industries.
Update: EU Medical Device Regulation Deadlines Extended
European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) raises the bar for device safety. However, ongoing challenges have resulted in a new extension [...]
Key Priorities for Proactive EHS Risk Management
In 2021, the U.S. Occupational Safety and Health Administration (OSHA) conducted over 24,000 inspections, most of them without advance notice. For manufacturers, it raises the question [...]
7 Ways to Enhance Quality Management Training
In regulated environments, quality management training is a requirement for good reason. A workforce with proper training is key to improving quality and minimizing issues that affect [...]
Understanding OSHA Form 300
Based on OSHA Form 300 data, the U.S. Bureau of Labor Statistics reported 2.6 million nonfatal injuries and workplace illnesses in 2021. While respiratory illnesses declined from 2020, [...]
Why Manufacturers are Integrating EHS and Quality
Quality management and environmental, health, and safety (EHS) have traditionally existed as siloed processes and roles in most organizations. It’s easy to see why, given the forces th [...]
FDA Warning Letters Show Document Management System Issues in Food Industry
Documentation is a subject that comes up frequently in U.S. Food and Drug Administration (FDA) warning letters and 483 observations. In fact, documentation is cited in virtually every [...]
