Activity

  • During the maturity phase of the product life cycle, it is important to be FDA and EU compliant. This product is now on the market and is used for real people. These FDA and EU guidelines are in place to ensure a safe and effective device throughout the entire life cycle. In the maturity phase, the SOPs and specs and all the documentation that follows the device must be highly detailed and FDA compliant. The Quality and Regulatory departments of medical device companies are highly valued during the maturity phase of the device. It is also important to respond effectively and satisfactorily to complaints that may arise once the device has been out on the market in order to stay on the market. Complaints, depending on their level of severity, can make or break a device. For this reason, CAPAs must be well maintained and executed.