Technical articles
20/02/2025
Predictive Maintenance: Beyond All-AI, A Gradual Approach to Industry 4.0
In modern industry, maintenance has become a strategic element ensuring companies’ competitiveness and operational efficienc
17/10/2024
Management of user interfaces of unknown provenance (UOUP) in medical devices according to the IEC 62366-1:2015 + A1:2020 standard
With the implementation of European Regulation (EU) 2017/745, both the official texts and the authorities are placing particular e
2/07/2024
Medical Devices: Now Introducing the Medical Visit Charter!
The Medical Device (MD) and In Vitro Diagnostic Medical Device (IVDMD) sector is subject to increasingly stringent regulations.
16/05/2024
Regulatory and Standard Monitoring: Staying the Course Towards Compliance
Whether in the life cycle of a medical device (MD) or an in vitro diagnostic medical device (IVDMD), it is not uncommon to face un
15/01/2024
Ensuring the safety of medical devices, an essential tool: risk management according to ISO 14971:2019
IntroductionMedical Devices (MD) and In Vitro Diagnostic Medical Devices (IVDMD) shall be designed and manufactured to ensure thei
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6/11/2023
ICH Q12 application for the implementation of a change: example of a site transfer
The ICH Q12 guideline entitled « Technical and regulatory considerations for pharmaceutical product life cycle management” is
3/04/2023
MD: the role of pre-clinical data in technical documentation (MDR & ISO 13485 :2016)
Medical devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way
15/12/2022
How to implement the IEC 60601-1 standard when placing medical electrical equipment on the market
ScopeIEC 60601-1 is the umbrella safety standard for medical electrical (ME) equipment. As its name suggests, ME equipment re
20/10/2022
Changes to medical devices (MDs / IVDMDs)
Once CE marked The life of a medical device is not a long, quiet river… Who has never attended a team meeting on a change t
9/08/2022
Advertising for medical devices (MDs / IVDMDs)
Since 1 January 2013, regulations on advertising have applied not only to pharmaceutical companies, but also to manufacturers of m
7/07/2022
DMDIV: Gradual implementation of regulation (EU) 2017/746
Since 26 May 2002, the placing on the European market of all IVDMDs has been subject to compliance with Regulation (EU) 2017/746 &
7/07/2022
MD marketing in the USA: what are the steps of the 510(k) submission procedure?
Why market a medical device in the United States?The USA is currently the largest medical device market, accounting for 45% of the
