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.
Smart process automation promises to cut complexity and transform product traceability in the medical device industry. However, its potential relies 100% cent on having good, reliable data on which to draw.
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
Both paper and digital paper are outdated approaches to medical device quality management.
This two-part virtual workshop will guide participants through the process of how to write effective documents.
The report also found that medical device companies are taking “huge gambles” in the area of risk management.