risk management

MedCity Influencers

Understanding ISO 14971 medical device risk management

Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. EVERY INTERNATIONAL REGULATORY AGENCY YOU’VE EVER HEARD OF ACCEPTS ISO 14971 AS THE RISK MANAGEMENT STANDARD FOR THE MEDICAL DEVICE INDUSTRY. ISO 14971 […]

Hospital patient profiling plan reads like a Daily Show story

If this story didn’t have a Bloomberg byline, I would swear it was from last night’s edition of The Daily Show. Hospitals are now buying consumer purchasing data to figure out who smokes, who has a car, and who shops at Walmart or Whole Foods. The idea is to identify high-risk patients and help them […]