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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..


standards, european commission, IEEE, MDD, Medical Devices, BSI, medical device field, medical device manufacturer, country code, FDA, ASTM, RTCA

Keeping Up With Regulations

In the medical device field the name of the game is Compliance. The reason for..

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:..