3 Replies Latest reply on Feb 4, 2016 2:05 PM by noel_asunx

    PADS PCB Design software and regulated standards

    noel_asunx

      I work for a medical device company.  We design and manufacture medical devices. We are considering PADS PCB Design software for our engineers.  I had a question that I hope you can help me with.  I've looked online, but haven't found any info thus far.

       

      As with other regulated fields, since we are a medical device manufacturer, there are guidelines and requirements we must follow with the Food and Drug Administration, namely 21 CFR Part 11.

       

      21 CFR Part 11 is defined as:

       

      "Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a))."

       

      Is PADS software, 21 CFR Part 11 compliant or following regulated standards?

       

      Thanks for your help!!