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Колекция Стандарти за медицински изделия
Collection Standards on medical devices
General information
Buying
Published
Scope
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
NOW
PUBLISHED
Колекция Стандарти за медицински изделия
60.60
Standard published
Dec 19, 2022