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Колекция Стандарти за медицински изделия

Collection Standards on medical devices

Aug 15, 2023

General information

60.60     Dec 19, 2022



None of the other values

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The collection includes the most demanded and widely applicable standards on medical devices. Three of them - BDS EN ISO 13485:2016, BDS EN ISO 14971:2020 and BDS EN ISO 15223-1:2021 - are harmonized under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
The standards in the collection enjoy considerable international success and provide a proven framework for the requirements related to the quality management of medical devices; the risk management process throughout all phases of the medical device life cycle; symbols used in information provided by the manufacturer and requirements for information provided by the manufacturer for medical devices.
This collection gives you a 54 % discount on the total price of the standards included.

Life cycle


Колекция Стандарти за медицински изделия
60.60 Standard published
Dec 19, 2022