AssurX Blog
Straight talk for regulated industries.
How Will Real-World Evidence Impact 2017 FDA Guidances?
The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug Administration (FDA) to understand that medical device manufacturers want clarity on FDA's heightened foc [...]
CDRH Report: Quality Management Insights For Medical Device Manufacturers
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 perta [...]
Cloud Computing Impact in the Energy and Utilities Sector
Technology-averse energy & utilities companies are about to embrace the power of cloud computing technology, say many leading experts. Cloud Computing Technology = Enhanced Perform [...]
Prioritize QMS Process Automation or Risk Failure
A common pitfall in QMS process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at once and streaml [...]
Successful QMS Implementation Requires Clearly Defined Processes
Industry-leading quality management systems (QMS) are built with clearly defined processes and workflows developed by the implementation team. While initially it may seem overwhelming, [...]
China Addresses Life Sciences Regulatory Compliance Concerns
China has often faced criticism for lax regulation of drug and medical device manufacturing. In addition, long-term accusations of bribery for inspection favoritism is still a real con [...]
