Content by AssurX
What to Make of FDA’s Secret Cache of Device Adverse EventsQuestions linger about FDA processes that seem to favor medical device companies
Wed, 05/08/2019 - 12:03
Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices. According to the report from Kaiser Health News, “Since 2016, at least…
AssurX GDPR Compliance: Benefits and Lessons LearnedDiving into every system that processes personal data

Tue, 07/31/2018 - 12:01
Proposed in 2012 and now in effect, the general data protection regulation (GDPR) is the newest landmark of data protection legislation. GDPR compliance legislation is designed to better protect personal data of individuals in the European Union (EU…
Elements of a Modern Change Management SystemIntegrated, flexible change management systems have higher adoption rates
Wed, 03/21/2018 - 12:02
When a change management system is designed effectively, it defines how strategies, procedures, and technologies will be applied to address changes in the business environment. Implementing a change management process for quality and compliance…
How to Leverage an EQMS for Managing Product AdulterationA document management system is now a compliance best practice
Wed, 02/14/2018 - 12:01
Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017, the FDA cited adulterated products and insanitary…
Medical Device Manufacturers Warned for CAPA NoncomplianceFDA warning letters indicate the agency continues to be concerned about noncompliance
Tue, 08/01/2017 - 12:01
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern. Inadequate corrective actions An FDA…
How Will Real-World Evidence Affect 2017 FDA Guidances?Medical device manufacturers want clarity
Wed, 06/14/2017 - 12:01
The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE). Responding to the…
Quality Management Insights for Medical Device ManufacturersCDRH is walking the talk and expects device manufacturers to do the same
Wed, 05/31/2017 - 12:01
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers. The CDRH continues to…
Prioritize a QMS Process Automation or Risk FailureSet small, achievable milestones and allocate reasonable time for analysis
Tue, 05/23/2017 - 12:01
A common pitfall in quality management system (QMS) process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at once and streamline the entire eQMS process in one…
Tougher Quality Management Enforcement Possible by FDANew regulations on combination products, and an unknown future as new chair appointment still pending
Tue, 03/07/2017 - 12:03
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape. In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress…
Utility NERC Compliance Programs Challenged by New Risk-Based ApproachSolid record-keeping and document management are key
Mon, 01/09/2017 - 11:05
If compliance with the North American Electric Reliability Corp. (NERC) Reliability Standards wasn’t complex enough, registered utilities must also factor in the regulatory nuances of the bulk power system’s (BPS) eight regional entities (RE), even…