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medical devices

  1. flyonthewall
    Thread

    CER Cleaning

    Hello, Are there recommended cleaning solutions/disinfectants for cleaning an ISO Class 7 CER (i.e., walls, floors, ceiling)? This would be done...
    Thread by: flyonthewall, Apr 24, 2024, 1 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  2. Ana Silva
    Thread

    ISO13485: Marketing materials and design files

    I work at a startup as a QA/RA and am working on document control. I am trying to figure out which marketing and design documents needed to be...
    Thread by: Ana Silva, Aug 24, 2021, 4 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  3. Stephen Lennon
    Thread

    ISO 13485:2016 clause 8.2.4

    Good Afternoon all, This is my first post to the Forum! I have a question surrounding ISO13485:2016 Clause 8.2.4, mainly ensuring objectivity...
    Thread by: Stephen Lennon, Feb 16, 2021, 3 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  4. John Thacher
    Thread

    Doing Less Change Orders by Allowing Part Interchangeability

    I work for a mid size medical device manufacturer specializing in general assembly and medical kit manufacture. We have a large number of products...
    Thread by: John Thacher, Dec 16, 2020, 1 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  5. Amy G
    Thread

    Article 12 Procedure Pack Labelling Requirements

    Hi, After some advise.. we are manufacturers of procedure packs under article 12. For certain components that can not be sterilised or...
    Thread by: Amy G, Oct 2, 2018, 1 replies, in forum: EU Medical Device Regulations
  6. subbash
    Thread

    Clarification regarding tests in IEC 60601-2-25

    I am new to testing the ECG device as per IEC 60601-2-25 standard. I want to test a battery operated ECG device, which can work in 6 lead or 12...
    Thread by: subbash, Aug 8, 2018, 0 replies, in forum: Medical Devices (21 CFR Part 820)
  7. Emilia
    Thread

    "Catch up" 510k

    Hello! I am looking for some input on the idea of a "catch up" 510k. When you have made several minor changes that only required a letter to...
    Thread by: Emilia, Sep 13, 2016, 3 replies, in forum: Medical Devices (21 CFR Part 820)
  8. MarkMeer
    Thread

    EMC IEC 60601-1-2 Testing for General Wireless Connections

    Hoping someone can shed light on the following situation: We are considering developing a device that is intended to communicate wirelessly with...
    Thread by: MarkMeer, Apr 15, 2016, 3 replies, in forum: IEC 60601 - Medical Electrical Equipment Safety
  9. Ronen E
    Thread

    2015 Annual FDA Medical Device Quality System Data

    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM490768.pdf?source=govdelivery&utm_m...
    Thread by: Ronen E, Mar 17, 2016, 2 replies, in forum: Medical Devices (21 CFR Part 820)
  10. Ronen E
    Thread

    FDA addresses devices service, maintenance, refurbishment and alteration by OEM and 3rd parties

    "Today the FDA opened a docket for public comment titled, “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing...
    Thread by: Ronen E, Mar 4, 2016, 0 replies, in forum: US Medical Device Regulations
  11. Rotta
    Thread

    AQL specified in a standard

    The ANSI/AAMI PB70:2012 standard for surgical gowns specifies an AQL of 4%, and defines it "... the quality level that for the purpose of sampling...
    Thread by: Rotta, Feb 18, 2016, 2 replies, in forum: Sampling, Standards and Inspection
  12. MarkMeer
    Thread

    Notified Body Debacle

    Hoping for some advice/comments regarding our difficulty sourcing a Notified Body (NB). Here's the situation: - We're not based in the EU, but...
    Thread by: MarkMeer, Jan 25, 2016, 14 replies, in forum: EU Medical Device Regulations
  13. Nash Jan
    Thread

    LAL Testing Frequency

    We manufacture single use syringes mainly used for orthopedic surgeries for administration of anaesthetic agents. We claimed supplied devices as...
    Thread by: Nash Jan, Sep 17, 2015, 4 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
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