Risk-controlled approach when evaluating clinical data of rectal suppository medical products
DOI:
https://doi.org/10.18372/2306-6407.1.17150Keywords:
risks, clinical data, suppositories, medical productAbstract
Risks during the introduction of a medical product (MP) into circulation and the development of technical documentation during the MP development are discussed. Ways to conduct clinical evaluation of medical products in the form of suppositories for rectal use and formation of the evidence base in relation to the levels of clinical effectiveness and safety of MP are considered. It was concluded that a risk-controlled approach helps to evaluate clinical data for the possibility of development and further production of the of the studied product.
References
Формування Технiчного файлу [Електронний ресурс]. https://cratia.ua/uk/conformity-assessment-medical-devices
Технiчний регламент щодо медичних виробiв (постанова Кабiнету Мiнiстрiв України вiд 2.10.2013 р. № 753).
Dmytrenko O., Arkhypova M., Starosyla D., Rybalko S., Gevorkyan M., Galkin A. Biological Evaluation of Medical Devices in the Form of Suppositories for Rectal and Vaginal Use // Innovative Biosystems and Bioengineering. — 2021. — Vol. 5, No 4. — P.228–237. https://doi.org/10.20535/ibb.2021.5.4.249082
