AssurX Blog
Straight talk for regulated industries.
FDA Acts to Harmonize Global Adverse Event Reporting
FDA Acts to Harmonize Global Adverse Event Reporting - It's a small world after all. One of the by-products of globalization is the speed and spread of everything from t-shirts to medi [...]
Medical Device Warning Letter Round-Up: FDA Won’t Take No For an Answer
This latest round of medical device warning letters is all about pushback. The FDA is not happy with the responses it received from Acme Monaco Corp., a New Britain, Connecticut-based [...]
The Six C’s of Document Management Best Practices for Life Sciences
Implementing a best-practice solution for any quality process is essential to help an emerging Life Science company ensure compliance and quality for their organization. Especially wh [...]
Partnership of Productivity Tools Will Allow You to Focus More on Creating Quality Products
Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc. In 1908, the first Model T was created and more than 15 million were sold through mid-19 [...]
Medical Device Industry Endures Tough 2013; 2014 Prospects Not Much Better
It's March, but you could forgive medical device industry leaders if they're still smarting a bit from a generally tough 2013. Several new studies indicate a low level of mergers and f [...]
The Six C’s of Complaints Management Best Practices for Life Sciences
Jeff Mazik, Vice President, Life Science Solutions, AssurX Companies in the Pharmaceutical, Medical Device, and Biotech industries must meet many regulatory requirements for a number [...]
