Regulatory Affairs

PFAS in Medtech

Per- and polyfluoroalkyl substances, known as PFAS, are a broad class of over 12,000 substances that are found in a variety of consumer, commercial and industrial products, including medical devices…

Regulatory Affairs

Artificial Intelligence in Medtech

Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…

cover of fact sheet
Ethylene Oxide / Government & Legislative Affairs / Regulatory Affairs

Fact Sheet: EtO Sterilization Prevents Infection

Each year in the U.S., ethylene oxide sterilizes 20 billion medical devices, which are critical to preventing serious, even life-threatening, infections.

technician repairs medical device
Government & Legislative Affairs / Regulatory Affairs

Third-Party Servicing of Medical Devices

Proper servicing of complex, life-saving medical devices is vital to their safe and effective functioning and the safety of patients and device users.