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.
In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
As COVID-19 sweeps the globe, it’s becoming increasingly difficult for medical device leaders to navigate the arising challenges and prepare for the future.
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.