Ten Best Practices for Medical Device Global Labeling Strategy:
Addressing common challenges for medical device manufacturers, and identifying effective practices to eliminate errors, manage organizational and regulatory change, and expedite time to market.
The medical device industry is highly regulated by the FDA in the US, and many regional bodies internationally, including the EU MDD (Medical Device Directive) and the ASEAN MDD. These agencies detail requirements for the life cycle of medical devices from design, trials, documentation, labeling, packaging, delivery, and adverse event reporting – all in the name of maximizing device safety and providing the greatest opportunity for positive patient outcomes. Managing this life cycle poses many challenges, most notably the challenge of meeting diverse requirements set by regional and local markets, and the constantly evolving nature of these requirements.
Before looking at how to construct potential solutions, learn more about the challenges that our Global Labeling Strategy will have to meet.