In March 2023, EU 2023/607 was published to amend the Regulation to extend the transitional provision therein. The main purpose of the extension is to allow Notified Bodies to have more time for reviewing legacy devices and issuing CE-Certificates within the EU MDR framework. This change also allows for additional time to submit MDR applications […]
Misconceptions Regarding the EU MDR Extension Read More »
GENERAL QUALITY TOPICSThe landscape of regulatory compliance in the pharmaceutical and life sciences industries is continually evolving. Companies operating in these sectors are subject to scrutiny from regulatory agencies, particularly the U.S. Food and Drug Administration (FDA). In recent years, FDA enforcement actions, including Form 483s, Warning Letters, and Consent Decrees, have been increasing in both frequency
Navigating FDA Enforcement Trends Read More »
GENERAL QUALITY TOPICSThe life sciences industry, which includes pharmaceuticals, biotechnology, and medical devices, demands the highest level of precision and compliance. However, human error can often lead to Good Manufacturing Practice (GMP) deviations, jeopardizing product quality, safety, and regulatory compliance. In this blog, we’ll explore strategies to reduce human error, describe the process, and highlight how MEDVACON,
7 Strategies for GMP Compliance Read More »
GENERAL QUALITY TOPICS