Over the last year and a half, so many things have changed. We’ve had to adopt new practices to ensure the safety and wellbeing of not only ourselves, but also our friends, family and the general public. Aside from working from home, one big change for medical device manufacturers is in auditing. We’ve completely shifted […]
I think it’s safe to say that returning to work is going to look very different in a post-pandemic life. Or what we are now calling the ‘new normal’. Many of us are now used to working in our pajamas and rolling right out of bed into our desk, but we will eventually have to […]
Changes in ISO 14971:2019 mean a big change to the medical device industry. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019. The last time this standard was released was 2012, so buckle up folks because this new Risk Management Standard is going to be one roller-coaster ride.
How exactly does one go about picking the right medical device equipment calibration vendor? While that itself is a loaded question and might require a sabbatical, a couple gallons of coffee and some pizza, I’m hoping that this blog can help you narrow your choices and approve the right vendor without stress.
When selecting a method for developing an assay, whether it is for detecting bacteria or simulating fluid, the approach all depends on the application and your target market. For example, Escherichia coli (or E. coli as it is more commonly known) can be found everywhere, from lettuce sold at a supermarket to your kids’ diaper. […]