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Dear Buket, thank you for your mail. Unfortunately, I cannot help, as I have retired and do not follow the developments in the area since early 2023. with best regards Pter Mik

Dear Colleague,  underneath please find my thoughts.   Isn't body orifice part of skin? What's the difference here in mode/point of application? I think you may relay on Wikipedia Body orifice - Wikipedia. Human body orifices used for medical device applications are: mouth, ear canal, nostrils, ...

Dear Colleagues, you may find good guidance for these and similar cases in an EMA document at Medical devices | European Medicines Agency (europa.eu) (to find the relevant sections  scroll down on the page) regards ------------------------------ Peter Mikó M.D ArtPharm Ltd. Gyermely Hungary ...

Dear Colleague, I do not know definite requirements. In case there are applicable standards for verification, those certainly should be applied for each versions of SaMD (eg. verifiying SaMD on PCs that analyses records of Holter monitors  accoring to IEC 60601/2-47:2012). For all the others I would ...

Dear Colleagues, after reading the 1st mail, my understanding is, that the concerned syringe containing the diluent of the medicine is part of the finished pharmaceutical product, therefore for the approval of the Marketing Authorisation of the medicine, the syringe in the EU needs to be either ...