Anyone have insights into marketing a 510k device with off label uses? There are strict rules of course, but still avenues for sharing information. Thoughts?
As originally asked by Brad Brenner. Jennifer Finetti Communications | Writing | Advocacy | Marketing | Outreach for Education / Higher Ed, EdTech and more Marketing and promotion of off-label uses is strictly prohibited and highly regulated. The onl...
Is there any specific time line to update the labels including the UDI/human readable requirements for the *Class* *I* and *Ir* devices.
As originally asked by Mark Driscoll, P.Eng., Ph.D. Please share with me your experiences in acquiring the 13485 certification. More specifically, for a start-up medical device company, is it advisable to move through the process internally or hire e...
Organizations today are faced with a growing list of new and changing standards, and keeping pace with them has become increasingly difficult. It’s hard enough to manage regulations in one country, much less multiple countries. How are the most effic...