The ISO 13485 standard is an international standard that establishes requirements for quality management systems applied to medical devices and is used worldwide as a framework to ensure the quality and safety of medical devices. The primary objective of the ISO 13485...
The new European regulations are generating a lot of commotion. And this, what is it due to? In this article we want to tell you what the new regulations say regarding the validation and verification of software in medical devices under the new MDR/IVDR european...
The new European regulations MDR (2017/745) and IVDR (7017/746) are based on a series of harmonized standards. In this article we will delve into the harmonized standards for obtaining the CE marking of our medical or in vitro software-type product. The following...
To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.