As the underlying risk management process for medical devices, the ISO 14971 standard is a critical component of regulatory and quality compliance. When new versions are released and harmonized, it’s up to manufacturers to learn about the changes to update systems accordingly. However, there is often a gap between the time a new version is released and when regulatory organizations require compliance.
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Brain disease | iso 14971 | risk management | Harm | Sequence of Events | Hazardous Situation | sterilization | Hazard
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.
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standards | iso 14971 | risk management | Standards Compliance
“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.
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trade | MDD | Medical Devices | trade deadline | trade-off | nhl | iso 14971 | risk management | 14971 | FDA | business risk | cmdr
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.
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standards | MDD | iso 14971 | medical device | Medical Device Directive | ISO | iso 13485
Making Sense of Standards
You may have heard that last year there were two new releases of EN standards: EN ISO 14971:2012 and EN ISO 13485:2012. What does this mean to you? What are the changes? How much does this affect the way you do business? Compliance to standards can be somewhat overwhelming. After a little digging into the changes to EN ISO 14971 and EN ISO 13485, hopefully I can provide you with a little clarity.
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