The United Kingdom’s plan to leave the European Union now has PM Boris Johnson at the helm and (seemingly) a hard deadline of Oct. 31, 2019. Zaid Al-Nassir's breakdown for medtech leaders has been updated to include events taking place through Aug. 1, 2019.
An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.
When OEMs choose an outsourcing partner, they need to trust the effectiveness of the supplier’s CAPA program, and they need to trust that the supplier’s culture sustains quality each and every day, for every device.
Human-factors engineering (HFE) is gaining increasing attention, especially in the context of medical device product development. As technologies evolve, therapies advance, and devices become more complex, so does the role of HFE increase in priority.