Industry experts highlight the importance of regulatory, quality, and marketing teams working together to ensure truthful medical product advertising. They also emphasize that regulatory oversight
Former FDA officials urge ex-agency employees to leverage and translate their regulatory experience into business terms when seeking private-sector roles. They stress that combining FDA
QualityHub Principal Consultant Jaime Santana has seen his fair share of strange FDA inspection scenarios over the many years he’s spent in the MedTech and
Former FDA investigator Lori Carr and Alson & Bird litigation attorney Dan Jarcho share their memories of US v. Utah Medical Products, a landmark GMP
Following a sweeping Reduction in Force (RIF) that displaced thousands of US government employees, including many at the FDA, former agency officials are navigating new
A veteran MedTech leader has demonstrated exceptional skill in maintaining manufacturing continuity through some of the world’s most challenging supply chain disruptions. Through decisive action,
Medical device manufacturers operating in the highly regulated MedTech sector should engage proactively and strategically with the FDA, advises Sean Boyd, QualityHub’s corporate VP and
QualityHub regulatory expert Rebecca Fuller will lead key sessions at KENX’s MedTech and GMP University, offering practical guidance on risk management, DHFs, post-market surveillance, and
Austin Griffing has joined QualityHub as Vice President of Business Development. With a strong track record in life sciences business growth and team leadership, Griffing
Successful document control in medical device and pharmaceutical companies hinges on understanding the audience and involving all relevant stakeholders in document creation and review. Maintaining