Two worldwide standards that stand out in the context of quality management are ISO 9001 and ISO 13485 Certification. They are both quite popular but they meet different needs of different sectors and have certain standards. This is where we at I3CGlobal come in to assist companies to acquaint themselves with these standards for compliance and…
Manufacturers of medical devices that wish to enter the U.S. market must follow the FDA’s 510k procedure. “How long does it take to get 510k?” is one of the most frequent inquiries that businesses ask. However, the answer would have depended on various factors, but learning the process will help you skip unnecessarily long waits and…
If you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how and when to file the 510k application. If submitted too early, it can add to delays, more costs, or even recalls; submitted too late, it cannot be included in subsequent batches. At…