This two-part virtual workshop will guide participants through the process of how to write effective documents.
This educational event will help medtech manufacturers learn about one of the most complicated aspects of quality system requirements.
Here are the most read articles of the year.
When outsourcing these key functions, asking the right questions will help minimize the risk.
With the heightened supplier scrutiny, it’s time to reevaluate your supplier quality program.
Excessive focus on compliance can create hurdles in cultivating quality and innovation.
The program intends to promote quality in medical device design and manufacturing.
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
An FDA inspection should never be confused with a notified body audit.
Entering the Japanese device market requires an excellent regulatory team.