Regulatory/Legal
Jun 15, 2015
An industry survey finds that more than half of surveyed medical device companies conduct early feasiblity studies outside the United States. What's needed to...
Jun 04, 2015
Worried about a repeat of last year’s Open Payments data disaster? One expert has tips for medical device companies on how to make the data validation...
Jun 02, 2015
Here are some tips for medical device manufacturers to effectively implement the UDI rule and facilitate improved patient care and supply chain management....
Jun 01, 2015
An expert explains why it is worthwhile for suppliers to make software validation easier for medical device manufacturers. David A. Vogel, PhD Validation...
Jun 01, 2015
The call for improved medical device surveillance gets louder, with stakeholders pressing for public and private sector fixes in the name of device safety. Jim...
May 27, 2015
You know you need a validation master plan, but what should it include and what separates a strong validation master plan from an ineffective one? Marie...
May 26, 2015
One hospital safety expert, who admits she'd be scared to be admitted to a hospital, explains what needs to change to make hospitals safer. Marie Thibault It'...
May 21, 2015
With new draft guidance making it clear that FDA is amenable to it, now may be the right time to take another look at adaptive design for your medical device...
May 18, 2015
The proposed 21st Century Cures Act legislation represents a rare level of cooperation between patients, industry, healthcare professionals, FDA, and...
May 15, 2015
Feedback on a plan to set up a medical device postmarket surveillance system applauds the overall idea but points out potential hurdles. Marie Thibault...