Question
Veteran device CEO Joseph Gulfo says, "The FDA must be challenged (when appropriate) because it operates in a highly political environment and has strayed from its original mandate." His full 2016 10x Medical Device Conference talk, slides, and trans...
Recently some of my clients received 483 observations for supplier controls and MDR reporting, but one of my clients asked which areas are FDA inspectors emphasizing. I noticed no significant changes, but I thought it was worth revisiting my Pareto A...
Justyna-Wanda Niewiadomski, MBA
Director Group R&D Quality & Clinical Affairs Management bei Sonova Gruppe bei Sonova Gruppe
May 2016
To get an CE Mark for a device which needs to go to a clinical study and do not have any results to proof the safety and performance requirements. Is there a similar process/procedure in Europe like in Us for the IDE (Investigational Device Exemption...
In late 2014 and the beginning of 2015 I wrote a three-part series of blogs about controlling nonconforming product. The blogs explained the three steps for controlling nonconforming product: 1) identify and segregate, 2) disposition of nonconforming...
Hello All: In ISO 14971 Medical Devices--Application of Risk Management to Medical Devices clause 4.3 is "Identification of Hazards." It requires the manufacturer to compile documentation of known and foreseeable hazards associated with the medical d...
Hi,I wonder if there is someone in here who knows of a standard which includes a symbol that conveys "reclosable packaging"? I have only seen such symbols on food containers, but do you know or think it would be possible also on a medical device cont...
This particular question seems to be a common nonconformity during audits. There are three reasons for this:the question is on several regulatory checklists for certification bodies,training on regulatory requirements is seldom provided to design eng...
Don’t ever believe what you hear. Instead, look it up. I think the software requirements are minimal in the newly released ISO 13485:2016 standard, but other experts disagree. In the QSR, software is also covered, and regulatory requirements are incl...
Recently I received an email inquiry from a LinkedIn group member that asked about the appropriate inspection requirements and operator certification for soldering electronic components to a printed circuit board for medical devices.The ISO 13485 Sta...
What will the regulators do in response to the 2016 changes?How do we revise our supplier controls?When will the standard be harmonized with the EU directives?In one of my previous announcements a couple of people responded to my announcement indicat...
