bench test

  1. I

    Bench Testing & Pre-verification vs. Formal verification

    Hi All, I'm having a challenging time with understanding what the difference between bench testing or pre-verification testing compared to formal verification testing with respect to how it relates to medical device development? My interpretation is that the term bench testing and...
  2. J

    Is Bench or Clinical testing better?

    Dear Experts, We are a medical device company that creates a wide variety of device. Currently, we are working on a blood glucose meter which is an IVD. We are going to perform bench testing of our meter to verify the meter's repeatability, reproducibility, accuracy etc. This testing...
  3. J

    Looking for Testing facility to do testing of x ray sensors for us

    Dear Experts, We have submitted a 510k submission for x ray sensors. FDA has gotten back to us and is asking for bench testing. We need someone who can execute the testing for us. Please let me if you can perform testing for us, or if you would recommend someone who might have experience...
  4. M

    Bench Testing Requirements for Class 3 devices

    we have been manufacturing class 111 devices. please let me know if bench testing as per iso 7206 , iso 14242 iso 14243 astm f 1820 astm f 2009 are required and necessary to get ce certificate and if yes where is it stated in the directive .also if u can suggest some labs who do these type of...
  5. M

    What is a Bench Test and how is it used?

    What is bench test? why we used to? :thanks:
  6. N

    Critical Analysis of Medical Device Bench Testing data

    As part of our device assessment process we have been asked to provide additional data on critical analysis of clinical trials and bench testing data. Critical analysis of clinical trials we have completed, however I am just wondering what exactly should constitute part of the bench testing...
  7. B

    Technical File Part A - Bench Testing

    Hello all, I currently work for a medical device company (class 2b) and am in the process of putting together technical files for our products. I am following the two part procedure (Part A and B). Can anyone shed some light on what exactly needs to be included for the bench testing summary...
  8. L

    Clinical Investigation vs. Bench Test - Definition

    Hi, Is every test with a medical device (before CE marking) in a clinical setting regarded as a clinical investigation? If not, what are the criteria to distinguish a clinical investigation from a bench test?
  9. S

    Bench Testing as part of 510(k) Submission

    Hi Everyone, I would like to know if we can include in the bench testing data from humans, animals and phantoms? I mean does anyone have experience with FDA auditors in that area? i.e. if I use data from different sources will they challenge that or what are they looking for in a mixed input...
  10. A

    Does the V&V (Verification and Validation) belong to Bench Testing for 510k?

    Hello cove-people We have a class 2 light therapy device for traditional 510k. For bench testing section 18 we have including our system spec, V&V, Risk analysis, trace matrix (BTW we software at low level of concern) Is this the proper domain for these documents? should we just leave...
  11. L

    Bench Test - Definition (in FDA context) and its difference with Clinical Study?

    Hello, all! Anyone can tell me the definition of Bench Test (FDA) and its difference against clinical study. If a test need the blood collected from human to evaluate performance of an IVD such as blood collection tube, is it a clinical study or a bench test? Thanks
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