Medical device companies have until March 1, 2019 to update their quality management systems to the ISO 13485:2016 standard. The simultaneous introduction of the Medical Device Single Audit Program and transitions to ISO 9001:2015 will leave manufacturers busy and certification bodies slammed. Therefore, it's important to start the process now.
Outcomes-based, data-driven decision making is expected to play a larger role in day-to-day supply chain management. This is not a discipline that every manufacturer possesses, nor can most manufacturers handle this shift on their own.
Involvement with numerous FDA inspections has given long-time BONEZONE author and lauded OMTEC speaker John Gagliardi a unique perspective on design control trends. Here are eight major design issues that he's observed over the years.
Your questions on postmarket surveillance. Ask here.