R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Foreseeing the Risks

On the news this morning, I heard a story that got me thinking about risk management. The headline was “Eight N.H. patients possibly exposed to fatal brain disease”. Further research about the situation reveals just how complex this case is.

“It’s like getting your high school diploma…”

Recently, I had the opportunity to attend a Risk Management Conference hosted by the FDAnews. At the beginning of the conference, we all went around the room and introduced ourselves, and indicated why we were there. Not surprisingly, a majority of people were there to have a better understanding of the new EN version of ISO 14971 - EN ISO 14971:2012, and learn how to implement it into their daily risk management activities.

Medical Device Development: Trades

As a somewhat rabid hockey fan there are a few days during the year that are considered sacred holidays: every playoff game, first day of free agency, and the trade deadline. My mind is on hockey because the trade deadline happens to be today. Outside of my insatiable desire to follow all hockey writers in the next 24 hours or so, I find myself thinking about trades in medical devices.

Regulatory Thoughts

Up until the time when I joined the RQS team in November all I had ever truly worked on was Quality. Coming out of college I worked for a plastics bottling manufacturer in process development and quality control. My next job was design V&V closely followed by design quality engineering and risk management. My exposure to regulatory affairs was at an arms length. I was always the person on the other end of a conversation where I was the one being told that I need to do something in a particular way because the regulations said so.

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