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Recorded Mark Roberts Understanding the alphabet soup of medical device standards – ISO, EN, BS EN, AAMI, etc Device approval, especially outside the US is driven by conformance to ISO, IEC and other standards. Recorded View Anytime $295.00 Mark Roberts Validating Radiation Sterilization for medical device industries Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. Recorded View Anytime  Duration:60 Minutes $295.00 Mark Roberts Design, Planning and conducting Effective audits Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Recorded View Anytime  Duration:60 Minutes $295.00 Mark Roberts Requirements of validation and control of EO Sterilization Ethylene Oxide (EO) has used for sterilization of medical devices for over 50 years. It is easily the most complicated of the common sterilization methods as it involves the most variables. Recorded View Anytime  Duration:60 Minutes $295.00 << >>