ASCA stands for Accreditation Scheme for Conformity Assessment. The procedure is intended to accelerate conformity assessments and, thus, approval procedures. However, it is not applicable to all devices or all markets. This article explains who benefits from ASCA and how the procedure works.
DetailsThe United Arab Emirates (UAE) with its hubs Dubai and Abu Dhabi is one of the most developed economies in the Middle East. The Emirates is among the wealthiest countries in the world. The healthcare system is considered highly developed, which is why the United Arab Emirates (UAE) is a popular health tourism destination in…
DetailsThe NIS-2 (Network and Information Security) Directive is a European directive (Directive (EU) 2022/2555) that sets minimum standards for cybersecurity within the EU. Does this directive also affect IVD and medical device manufacturers? If so, what does it require, and what should manufacturers do? This article provides answers.
DetailsThe requirements for clinical investigations to evaluate a device have increased enormously under the MDR. Learn the most important things you need to know about the regulatory pathway for clinical investigations under the MDR here.
The NMPA Usability Guidance affects many manufacturers of medical devices and IVDs, as well as manufacturers of combination products, who want to market their products in China. This article clarifies which devices must comply with the NMPA requirements regarding usability and what these requirements are.
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