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FDA Restarting Domestic Inspections

FDA Restarting Domestic Inspections

On July 10, 2020, the U.S. Food and Drug Administration (FDA) stated their plan on restarting onsite domestic inspections. In March, FDA had reduced inspections due to the COVID-19 pandemic, and they have only been conducting mission critical inspections over this...
Pre-Sub Process Recommendations

Pre-Sub Process Recommendations

A Pre-Submission (or Q-Submission) is a structured process for developing interactions between medical device manufacturers and FDA about a myriad of topics that ultimately point to future applications for approval or clearance, prior to the IDE, 510(k), PMA, or De...
Virtual Audit Planning

Virtual Audit Planning

Virtual audits are our current situation; yes, it’s a bit out of our collective comfort zone, but it beats not performing audits at all during this time of uncertainty. Quality System compliance can still be assessed no matter the environment, with a few key changes...
Mobile Medical Apps

Mobile Medical Apps

In today’s wireless world, it seems everyone has a smartphone and it’s revolutionizing how services and information are presented and accessed. In the healthcare industry, this means rapid advances in telemedicine and the development of mobile medical apps (MMAs)...