Technical articles
7/08/2024
Importance and design of PMCF studies for medical devices in Europe: framework and principles
Medical Device Regulation (MDR) 2017/745, which has been enforced since May 26, 2021, has significantly reinforced the regulatory
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.
18/06/2024
How to conduct a metagenomics project
Metagenomics, the science of genetic analysis of microbial communities, i.e., all the microorganisms (bacteria, viruses, fungi, ye
30/05/2024
Shared audits: a simple, cost-effective solution for suppliers, subcontractors and service providers
Suppliers, subcontractors and service providers are increasingly called upon by their customers to carry out assessment audits. Th
22/05/2024
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
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
17/04/2024
Focus on AET and TSL
Among the changes introduced by the 2023 version of ISO 10993-17 (Biological evaluation of medical devices - Toxicological risk as
5/03/2024
Literature review: a key element in DM development
The design of a medical device is a complex stage, requiring in-depth knowledge of available technologies, unmet clinical needs, e
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
12/12/2023
Metagenomics
Metagenomics is a method for studying the microbiome, i.e., all the microorganisms (bacteria, viruses, fungi, yeasts, plankton, et
14/11/2023
Efor accelerates the structuring of its center of excellence for health data valorization.
With a position among the leaders in specialized consulting for Life Sciences industries, the Efor Group supports its clients thro
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
