Posts by Azra Rajwani

Azra Rajwani

Big changes in ISO 14971:2019

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.

Azra Rajwani

Determining the best method to detect E. coli

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. […]

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.