It's not the end of the world, but there is a public forum I don't have privilege to reply to or start new posts:
elsmar.com
Medical Device Related Standards - Elsmar Cove Quality and Business Standards Discussions
Medical devices standards, national and international. Standards are published by standards writing bodies (such as ISO and IEC internationally, ANSI, CEN, CENELEC, CSA and others nationally) and are generally voluntary. You can use standards to fulfill regulations, depending on the way the...