Real-world evidence is becoming a core proof standard for MedTech manufacturers.
In this issue, Khalil Thomas explains why raw data is not enough, and why regulators, payers, and quality systems increasingly expect evidence that proves how products perform in actual use.
Things got a lot more interesting for AI in the US.
Yesterday, President Biden signed an #AI #ExecutiveOrder (EO) to promote responsible and equitable development and use of AI across the U.S. Govt.
5 Tips For Better CAPAs
Looking for ways to strengthen your CAPA program? Check out our 5 tips to keep your CAPAs effective, and out of 483s.
The FDA’s Cybersecurity Guidance for Medical Devices
Back in March, the FDA released a guidance on cybersecurity. Since then questions have risen as to how to how to incorporate the expectations into quality systems.
AI & Quality
Reflections on a conference talk about AI solutions in Medical Device Quality Systems
Health Equity, the Quality Professional’s Dilemma
In the midst of #HTLH2022 I've read some great posts about what #healthEquity means to different healthcare providers. Here’s my take for the Quality professional.
Careful of embedded AI
Embedded AI has incredible potential to improve healthcare. But if we’re not careful, we’ll end up making things worse.