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.
The challenge for the digital health community will be to bring the same high standards for care in the physical world to their digital interactions.
The absence of any of these disciplines can lead to blind spots that can introduce risk, but they are not all created equal.
Lucira Health’s single-use molecular test kit will be available for prescription home use in people age 14 and older.
All commercial, clinical, R&D and manufacturing activities surrounding the product will end.
Moving too quickly in the product development process can lead to mistakes.
And medtech companies need to keep interoperability and security top of mind.
Part three of this series discusses the key defenses available to each element of a lawsuit against providers and labs.
Despite the high stakes of data vulnerabilities to the entire healthcare system, governments in Asia lag behind in mandating cybersecurity measures, leaving manufacturers to install and maintain systems to protect against cyber criminals.