Waiting for answer This question has not been answered yet. You can hire a professional tutor to get the answer.

QUESTION

I will pay for the following essay Applying for a CE Mark for a Medical Device. The essay is to be 9 pages with three to five sources, with in-text citations and a reference page.Download file to see

I will pay for the following essay Applying for a CE Mark for a Medical Device. The essay is to be 9 pages with three to five sources, with in-text citations and a reference page.

Download file to see previous pages...

After surgery observation is conducted of the test species at appropriate intervals to note and record per 3.3.4 of the standard “any abnormal findings, including local, systemic and behavioral abnormalities” (p. 5).&nbsp. At the completion of the testing period, in this case 78 weeks the animals will be euthanized humanely in order to determine the biological response of the test area to the prolonged contact with the cement “by grading and documenting the macroscopic and histopathological test responses as a function of time” (p. 5) and comparing it with the control material (the rods) and the surrounding area.&nbsp. The examination will be facilitated by use of a low magnification lens of each test site material.&nbsp. After all of these results have been documented, the test and control tubes and rods and the surround tissue/bone shall be removed for further evaluation.&nbsp. Care must be used in the removal of the samples.&nbsp. Section 3.4.2 details the removal process:When the implant/tissue interface is to be studied, embedding of the intact tissue envelope with the implant in situ using hard plastics is preferred. Appropriate sectioning or grinding techniques are employed for the preparation of histological sections. It shall be demonstrated that the technique of embedding in plastics does not markedly alter the interface tissue (p. 5).All responses noted in the area surrounding the implant is to be documented and measurements were taken of distance to unaffected areas and the specific characteristics. of the normal tissue in relation to the implant area. It is important to follow protocol and record the location, orientation, geometry of the incision and the number of sections.

Biological assessment of the sections include per 3.4.3:

a) Extent of fibrosis/fibrous capsule and inflammation.

b) Degeneration as determined by changes in tissue morphology.

Show more
LEARN MORE EFFECTIVELY AND GET BETTER GRADES!
Ask a Question