Automating validation processes gives manufacturers the flexibility and capability to make changes, updates and re-validation, making it easier to upgrade or add new MES modules to their process. Simplifying the process through automation leads to faster ROI and time to market.
COVID-19 ushered in a fundamental change in how medicine is being delivered.
A review of common risks and pitfalls of incorporating artificial intelligence in medical devices and an overview of the regulatory framework.
A discussion with Peter Willemse about how configure, price, quote (CPQ) software can help medical device manufacturers deal with the nuances of everyday challenges and continue to drive revenue and increase profit margins.
Digital health tools and technology have the potential to dramatically improve the patient care experience, but the shift requires purposeful coordination and planned architecture.
It’s time to take stock on what temporary measures need to be made permanent to grow as an industry.
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
Labeling is as critical as quality for medical device products. If a manufacturer can’t shift labeling to meet production in an agile manner, their products may not reach their destination.
A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity.
The agency created the new post within CDRH, effective January 1.