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Life Sciences
Deviation vs. Nonconformance: What’s the Difference?
Recent headlines over wasted COVID-19 vaccines reveal shocking instances of lab workers not following key procedures, l [...]
All Roads Lead to ISO 13485: The Global Context
As regulations and standards evolve, one trend is continually sharpening in focus. ISO 13485 for medical device quality [...]
Are FDA Warning Letters and 483 Observations About to Spike?
The number of U.S. Food and Drug Administration (FDA) inspections dropped dramatically in 2020, with the agency postpon [...]
5 Quality Management Trends to Watch in 2021
2020 represented the sharpest economic slowdown in modern history. Nonetheless, with manufacturing orders reaching a thr [...]
Computer Systems Assurance: Making the Transition from Computer Systems Validation
For decades, pharmaceutical and medical device companies have operated under the assumption that they must document and [...]
AssurX Webinar – EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution
Join us for a one-hour webinar focused on efficient management of postmarket challenges faced by medical device manufact [...]
