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fda

  1. Thorsten Twellman
    Thread

    How to handle optional software feature that is part of a medical device, but not sold in the USA

    Hello community, We are planning to add a new software feature (a complex image processing algorithm) to our software product that is sold in...
    Thread by: Thorsten Twellman, Nov 25, 2024, 1 replies, in forum: Medical Devices (21 CFR Part 820)
  2. binnie
    Thread

    21 CFR Part 11 Electronic Signatures scanned

    The scanned electronic signature is acceptable to kept as electronic record? example, the report has needed to be signed by 3 approvers. 1st...
    Thread by: binnie, Jun 5, 2020, 4 replies, in forum: Qualification & Validation (Also 21 CFR Part 11)
  3. 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)
  4. 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)
  5. Jim Cullen
    Thread

    Quality Engineer job with a medical device company in Indiana

    Our client, a leader in medical device instruments and implants, is growing their team and seeking an experienced Quality Engineer to help with...
    Thread by: Jim Cullen, Jul 8, 2016, 0 replies, in forum: Job Openings and Employment Opportunities
  6. Ronen E
    Thread

    FDA proposes to ban powdered surgeon's & examination gloves

    "Today the FDA published a Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a...
    Thread by: Ronen E, Mar 22, 2016, 0 replies, in forum: US Medical Device Regulations
  7. 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)
  8. 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
  9. Ronen E
    Thread

    FDA releases safety communication on skull clamps

    The release follows a review of adverse events reported between 2009-2016....
    Thread by: Ronen E, Feb 25, 2016, 0 replies, in forum: US Medical Device Regulations
  10. Daliane
    Thread

    How to implement 820.20 (d) “ Quality planning“?

    Hello everyone, 21 CFR 820.20 (d) "Quality planning" requires a quality plan to ensure quality requirements. Since we (a German OEM) follow...
    Thread by: Daliane, Feb 8, 2016, 2 replies, in forum: Medical Devices (21 CFR Part 820)
  11. Nomi P
    Thread

    Equipment SOPs

    Is there a regulatory requirement (either ISO 13485 or FDA CFR) to have a written SOP/work instruction for each piece of laboratory equipment,...
    Thread by: Nomi P, Jan 28, 2016, 1 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  12. Ronen E
    Thread

    CDRH releases 2016-2017 strategic priorities

    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM481588.pdf?source=govdelivery&u...
    Thread by: Ronen E, Jan 13, 2016, 0 replies, in forum: US Medical Device Regulations
  13. MarkMeer
    Thread

    Pressure units for US labeling (atm, psi, or in-Hg)

    Wondering what the recommended pressure unit for US public is (specifically when labeling operational, transport and storage conditions)? I've...
    Thread by: MarkMeer, Jan 13, 2016, 1 replies, in forum: US Medical Device Regulations
  14. MarkMeer
    Thread

    Justifying NOT following an FDA guidance?

    Hi Everyone, Just curious: has anyone (successfully) attempted to push-back against an FDA observation that items in one of their guidance...
    Thread by: MarkMeer, Jan 5, 2016, 12 replies, in forum: Medical Devices (21 CFR Part 820)
  15. Daliane
    Thread

    CTD only for pharmaceutical products or also for IVD required?

    Hello everybody, our customer wants to export our microarray scanner, which is an IVD, to the US. They state, that for the approval process the...
    Thread by: Daliane, Nov 11, 2015, 2 replies, in forum: Medical Devices (21 CFR Part 820)
  16. Daliane
    Thread

    Comply with GMP 21 CFR (820) / excisting ISO 9001 and ISO 13485

    Hello everybody, we are a German OEM for medical devices. One of our customer will have the US as a new target market. So we need to comply with...
    Thread by: Daliane, Oct 30, 2015, 4 replies, in forum: Medical Devices (21 CFR Part 820)
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