Resources

What can life science companies do to prepare themselves in the current medical device regulatory environment? In this sound bite from RCA Radio, host Brandon Miller is joined by Jordan...

In Vitro Diagnostics Regulation (IVDR) Changes Listen to this In Vitro Diagnostics highlight from RCA Radio where Seyed Khorashahi breaks down the EU's move from list-based IVD device classifications to...

The U.S. Food and Drug Administration (FDA) recently updated its pharmaceutical manufacturing guidance on Continuous Manufacturing (CM), including elaborating on established industry best practices. Examples of new insights provided by...

In the pharmaceutical and medical device industries, quality culture plays an essential role in profit generation, product safety and approval from regulatory bodies. As a result, organizations must prioritize maintaining...

In the world of medical device testing, manufacturers should seek to identify key characteristics that set a high-quality laboratory aside from the rest. A successful medical device testing relationship should...

The US Food and Drug Administration (FDA) has recently expanded on its clarification of a virtual audit, and how new manufacturing protocols in the COVID-19 environment will evolve. Travel constraints...