Tag Archives: risk analysis

Avoiding FDA regulatory issues in your device development

Why Medical Device Startups Struggle With FDA Regulatory Approval: 10 Common Mistakes Quick Answer Medical device startups most often fail to reach market on time because they treat FDA regulatory compliance as a final step rather than building it into product design from the concept stage. The 10 most common causes of medical device startup

The new QMSR regulations – and Risk Analysis

We recently participated in FDA inspections using the new QMSR (Quality Management Systems Regulations). These inspections were very interesting. One was conducted at a foreign client in China the other was in the USA. These inspections went directly to the QMSR and expected that the companies were following the new regulations. If you are already

FDA Crisis Intervention

FDA Crisis Intervention Though we hope this never occurs, at times companies do run into situations they were not prepared for, or understand, while dealing with the FDA. We have seen this over and over again with our clients worldwide. These unexpected situations could be: A Surprise FDA Inspection Visit When the FDA gets information

Get your food defense plans ready!!

FSMA Final Rule for Mitigation Strategies to Protect Food against Intentional Adulteration!! The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Rather than targeting specific foods or hazards, this rule requires