This presentation provides an overview of the FDA's device pre-submission process and will examine the advantages of the Q-Sub program.
In this Ask the Expert video, experts discuss the new chapter, Chapter Bacterial Endotoxins Test Using Recombinant Reagents.
Click to learn how RCA's regulatory compliance consultants approach the MDR submission process & clinical evidence requirements for CE Mark.
Click to learn more from RCA's regulatory compliance consultants about biotech quality & how standard improvements help impact the industry.
Click to learn from RCA's regulatory compliance consultants about internal compliance for managing remediation & quality assurance expenses,
Click to learn more about why a quality risk management plan is an integral and valuable element of an effective…
Insights about what works and what doesn't in managing a product crisis, learned from real investigations of product failures.
Small or emerging life science organizations often put off hiring quality executives, exposing the company to risk or worse. Other…