Posts by Azra Rajwani

Azra Rajwani

Pros and Cons of Virtual Audits

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 […]

Azra Rajwani

Returning to Work Safely During COVID

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 […]

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. […]

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