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27/09/2024
ISO/DIS 10993-1, A New Revision Underway – Analysis of the ISO 10993-1 Standard Revision Draft
The draft of the new revision of ISO 10993-1, addressing the biological evaluation of medical devices (MD), was released at the en
12/09/2024
Quality Management System Regulation (QMSR), the FDA’s new regulation applicable to medical devices: We explain it all!
The QMSR, published by the FDA, imposes new requirements on medical device manufacturers. Discover the key changes to comply with
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
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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
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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
