New to medical devices and need an orientation of the creation of instructions for use (IFU)?  A good place to start may be a website prepared by Ferry Vermeulen, a director at INSTRKTIV.  In further preparation for the Medical Device Regulation (MDR) enforcement in the EU, Ferry prepared a guide on how to create IFU for...Read More

The U.S. Food and Drug Administration issued a Federal Register notice with a proposed program for Voluntary Malfunction Summary Reporting. When finalized, this program would allow manufacturers to report certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis instead of individually within 30 days. The proposed Voluntary Malfunction Summary Reporting...Read More

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm528236.htmRead More

/docs/FDAMDRGuidance110916ucm359566.pdfRead More

http://open.fda.govRead More

http://1.usa.gov/I40tfjRead More

http://1.usa.gov/1igjXM2Read More