2024/4/10 -Ensuring Compliance: Understanding the IVDR's Summary of Safety and Performance (SSP). The world of in vitro diagnostics is all about accuracy and reliability.
2024/4/15 -This guidance document is then relevant for compliance with the IVDR regarding safety reporting. MDCG 2022-10 provides further guidance on the interface between ...
2024/5/25 -Delve into IVDR's Summary of Safety and Performance for crucial insights and compliance essentials. Stay informed with our concise guide.
2024/5/15 -Is your software a Medical Device? March 2021. MDCG 2020-1, Guidance on clinical ... Preliminary re-assessment review (PRAR) form template (IVDR), May 2024. MDCG ...
2024/4/17 -In vitro diagnostic devices (IVD) include any medical device used in medical diagnosis, such as reagents, kits, instruments, equipment, and software. It is ...
2024/4/15 -Obtaining a CE mark for IVD devices is a complex process. Our consultants can help you navigate the IVDR CE marking process effectively.
2024/3/29 -This article talks about the medical device sampling and evaluation of technical documentation by NB to obtain a CE marking as per EU MDR/IVDR regulations.
2024/4/15 -What about Custom-made devices? What is a “significant change” under the EU MDR or IVDR? What transitional periods and conditions apply to legacy devices? What ...
2024/4/21 -Declaration of Conformity – MDR/IVDR · Product name and trade name · Product code(s), catalogue number(s) or other unambiguous reference** allowing identification ...
2024/5/8 -Discover the ultimate guide to harmonized standards medical devices! Our blog post provides outdated and inaccurate information about the latest regulations ...