Announcement

Collapse
No announcement yet.

RMS Hardware, EU MDR Complaint?

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • RMS Hardware, EU MDR Complaint?

    Hi Forum

    Does any one of you have experience with complying to EUMDR regulative, in regards of hardware used by Rotronic. (RMS-LOG-L RMS-with HCS-S or RMS-HCD-IC102)

    https://ec.europa.eu/growth/content/...-regulation_en

    Thanks in advance
    Best Regards
    Emil Larsen
    RMS-manager @ C.K. Environment A/S
    Dir. : +45 3144 2656 • Main: +45 4498 9906
    el@cke.dkWWW.CKE.DKRotronic Monitoring Systemswww.rotronic.dk
    LinkedIn

  • #2
    Hi Emil,

    If you check the regulation, Rotronic can help the manufacturer, authorised representative, importer or distributor of medical devices in the EU with the following points:

    Annex 1, Chapter 1, 7: Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.

    Annex 1, Chapter 1, 14.b: risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and acceleration or radio signal interferences.

    Annex 1, Chapter 1, 20.6: Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use.

    Annex 1, Chapter 1, 23.4.s: warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature.

    We have worked with a few manufacturers of medical devices in Switzerland where they are using RMS to help cover some of these points.

    Regards,
    James

    Comment


    • #3
      Hi...we are using Intel Xeon also with 32GB, what we fail was on our OS which only support 32GB RAM. It is sad because we have 78 existing stores and we encounter a slow connection and some hard to get worskheet to branches.

      rigid flex pcb design for assembly guidelines
      Last edited by PetrTecilla; 31-07-2020, 18:46.

      Comment

      Working...
      X