Category Archives: Medical Device

As we all know, there has been a lot of angst in the device industry as the FDA evaluates what to do next with regards to 510(k) reform.  Last year we posted a blog describing the challenges and uncertainty around … Read full article

by Nancy Singer, president, Compliance-Alliance, LLC  When people consider purchasing an electronic system to help them with CAPA, they sometimes wish it would ensure their compliance with FDA regulations. They want help from the system so their company will do everything correctly. … Read full article

As the regulatory landscape evolves and medical device companies look for guidance about Electronic Medical Device Reports (eMDR) and Electronic Medical Device Vigilance Reports (eMDV), I’ve found there are many misconceptions about how to comply with new regulations and even … Read full article

Recently, Sparta Systems contributed to PharmaLive.com’s 2011 Special report about Medical Devices.  Click here to view the full article.  Our Industry Principal, Tim Mohn, offered some insightful perspectives about the medical device industry; what’s changing and trends we expect to see … Read full article

FDA inspections are a fact of life for a wide range of organizations.  According to the budget request for fiscal year 2011, the FDA plans to hire more than 170 new inspectors in the field operations of the Office of … Read full article