Resources

The FDA Center for Devices and Radiological Health (CDRH) recently published new guidance for medical device priorities in 2023. The FDA CDRH guidance looks to evolve away from the COVID-19...

While audits are not being conducted in the same way they were before the global pandemic, they continue to take place. New procedures adopted to deal with the coronavirus outbreak...

In this soundbite from RCA Radio, Dr. Helin Raagel and Dr. Matthew Jorgensen from Nelson Labs explain biocompatibility testing. This includes the risk-based biocompatibility evaluation that medical devices go through...

Data integrity is the reliability, consistency, and accuracy of data at rest and in transit. Quality data adheres to several standards, beginning with integrity, confidentiality and availability. Data integrity is...

Whether building a new facility (greenfield) or upgrading a pharmaceutical manufacturing site (brownfield), it is important to understand the regulations governing facilities and inspection readiness. The Code of Federal Regulations...

The FDA harmonization team has recently announced it is no longer going to be a member of the Global Harmonization Working Party (GHWP). This comes as an eye-opener for many...