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  • If the app is to control the device (and only does this), it would be outside IEC 82304-1. IEC 82304-1 is the product standard for standalone software (including Software as Medical Device). IN the case of your device, the "product safety" standard is IEC 60601. Scope of 82304-1is: This Part of 82304 applies to the SAFETY and SECURITY ...

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    IEC 62133:2017

    In 2017, the IEC 62133 standard was split into two new standards, -1 & -2. -1 is for nickel chemistries, -2 for lithium chemistries. The question is I have is to when is  IEC 62133-2:2017 likely to be a recognized consensus standard with the FDA? regards Mike ------------------------------ Mike Kilkelly Quality Manager Galway Ireland --------- ...

  • See link Amicus Therapeutics is in search of a talented Associate Director, Global Labeling for our expanding Regulatory team in Cranbury, NJ. Excellent opportunity to join a rapidly growing global biotechnology company at the forefront of rare metabolic diseases! **Voted Best Place to Work 2018** http://chc.tb ...

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here


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