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single use devices (sud)

  1. F

    Reprocessing or refurbishing? Single Use Medical Device

    Hello all, I'm working as a not so experienced QA/RA Manager for a startup that is developing a class IIa medical device. Our product is intended as a single use and is composed of an electronic board powered by a single use battery, a casing and an adhesive to stick it on the skin of the...
  2. Marcelo Antunes

    Medical Device News ANVISA – Consulta Pública nº 584 de 20/12/2018 – Enquadramento de dispositivo médico como de uso único ou reutilizável

    ANVISA – Public Consultation nº 584 of 12/20/2018 – Framework of medical device as single use or reusable ANVISA – Consulta Pública nº 584 de 20/12/2018 – Enquadramento de dispositivo médico como de uso único ou reutilizável Continue reading...
  3. M

    New Medical Device Accessory with New Function - Is this a major change?

    We'd like to introduce a "fitting kit" disposable accessory that clinicians can use to test out on patients to see if the device is suitable for individual patients. I'm not clear how the addition of such an accessory would affect the regulatory status (510(k) cleared, CE marked, Canadian...
  4. S

    Contract Packager or Repackager? And can client assume responsibility?

    I have a situation with a very small client who is an initial importer of a Class II non-sterile, individually-wrapped, single-use device. They get this device supplied in retail boxes (over-the-counter) from the Contract Manufacturer which may include 20 single-use, individually-wrapped...
  5. I

    Label Expiration Date - Single Use Combination Medical Device

    I have a client that needs to prepare a label according to the EU requirements. the product include an electronic device, and a capsule with pharmaceutical liquid. Both components are marketed in the same package. The pharmaceutical has expiration date and is intended for single use, two...
  6. S

    IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Devices

    We have a medical device accessory (say electrode) needed for a medical device to work. It has its own packaging (and label). The packaging has print (text/instructions). Since this is a single use accessory, does the package print need to be fully compliant with section 7.1.3 Durability of...
  7. N

    Reliability Testing of a Single-Use (Disposable) Medical Device

    Hello cove, My company has a Single-Use device that composes with two parts, the handle and component A. The component A is a real single use device. The handle can use 8 times by changing the component A.In other words, during one surgery, one handle can utilize 8 component A's at a maximum...
  8. M

    "Single Patient Use" Terminology Confusion

    I've sometimes seen the common ISO symbol for "Do not reuse" (aka "Single Use Only") - a crossed out number "2" - referred to as "Single Patient Use". I think this is a bit of a confusing term, and should be avoided, because it can easily be interpreted as "Do not share between users", and...
  9. M

    Customer Requirements for Single Use Medical Devices

    Dear all, I new to medical devices industry, I planning to design a Customer requirement for our medical devices, kindly share some template which will be helpful for me. Please let me know Surgical textiles have Design control requirements as standards Regards, Muzammil
  10. S

    Is double packaging obligatory for surgical single-use scalpels?

    Hello all, I'm working at a company which provides regulatory consulting services for companies developing medical devices. One of our costumer is a company which its product is a surgical scalpel with a special agronomic handle (the scalpels are for single use and will be supplied...
  11. T

    Applicable Testing for Single Use Electrode

    Is there any required or applicable IEC/EN related tests for single use electrodes?
  12. somashekar

    Determination of Clean Room Class for Medical Devices

    When we look into the ISO 8536-4:2010 (Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed) and in this into the Annex A., which gives requirement of particulate matter and its assessment and acceptable value (N<90), how can we use this information as an...
  13. C

    Biocompatibility Evaluation Testing on Single Use Tube Sets

    Dear Members, Hope everyone is doing well. I need some guidance on evaluation on Biocompatibility testing. Intended use of our product(tube set) is to provide extracorporeal blood path during treatment similar to dialysis and therefore we need to perform biocompatibility test. This tube...
  14. M

    Re-Use of "Single Use Only" Medical Devices

    Per a news report today: Does this statement have legal effect, i.e. is this an official re-interpretation of the Directive/upcoming Regulation? Is there an ongoing rule/guidance development process to cause it to be implemented? If the report itself accurately summarizes the original...
  15. A

    Cleaning instructions for our non sterile, single use products

    Hi :bigwave: I have recently been asked for cleaning instructions for our non sterile,single use products.My first thought was are they reusing them, which they don`t. Could anybody tell me if you have to provide these instructions for non sterile single use products, if so a little bit of...
  16. Bev D

    Probability question - Components of Variation study on a single use diagnostic test

    OK - I'm brain dead today. I have a probability question: I am performing a "Components of Variation" study on a single use diagnostic test. I have 3 lots of the test devices and 3 different QC testers. Each tester tests 3 devices from each of the 3 lots. What are the odds that 1 of the...
  17. K

    Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary:

    · Right now the UDI rule is a pre-publication “proposed rule” (no actual regulations have been amended/promulgated yet). The proposed rule is due for publishing via FR next week. · Stakeholders will have 120 days to lodge comments/concerns with FDA before FDA initiates the...
  18. L

    EO Sterilization Cycle Revalidation Intervals

    Hi all - We manufacture mostly plastic Class I and IIa single use devices sterilized with EO gas. I typically run actual cycle revalidations every 3 years and then have paper revalidations conducted annually for the years in-between. My sterilizer is suggesting that I do the actual cycle...
  19. D

    Independent Testing of ECG Electrodes in accordance with AAMI standards

    I'm trying to find a company that can provide independent testing of Disposable ECG Electrodes in accordance with AAMI EC12-2000 standards; I have 12 - 24 products to be tested. Need to know: 1) how many parts are required for the test? 2) quickest turn-around time for test results? 3) cost...
  20. P

    Single Use Devices - Surgeon must have backup in stock, just in case?

    Has anyone ever experienced this?? We manufacture a Single Use Laproscopic Surgical Device that, if the Surgeon uses incorrectly, can be damaged. The fix is to just grab another one... and the problem is, that if they don't have a backup device, they are unable to finish the procedure! This is...
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