As the pace of innovation further accelerates in 2021, and the need to get new devices to market intensifies, maintaining adherence to regulatory controls is not enough.
The key is to keep quality high and risk low.
It’s time to take stock on what temporary measures need to be made permanent to grow as an industry.
Companies within the life sciences industry should rethink how they manage their data and documents.
Understanding the GMP requirements of each component is critical to product and compliance success.
It’s time to consider CAPAs as opportunities rather than just other issues to tackle.
Top reasons for recalls include software, quality and parts issues.
Moving too quickly in the product development process can lead to mistakes.
With digitalization impacting all areas of manufacturing operations, it should come as no surprise that medical device producers must adapt or risk missing the next wave of performance and product improvements.
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.