The Final Rule was mooted for implementation over a staged transition period, determined by a service’s risk level, by 2028.

DNV, the independent assurance and risk management provider, has been recognized by the European Commission as a notified ...

The global in vitro diagnostics (IVD) market has exhibited significant growth, with its valuation rising from $67,111 million in 2019 to an estimated $91,093 million by 2027. This ...

This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China ...

The Europe in vitro diagnostics (IVD) market has showcased significant growth, with its valuation increasing from $13,825 million in 2019 to an anticipated $18,647 million by 2027. This report ...

This report analyzes in vitro diagnostic (IVD) technologies and devices used in hospitals and point-of-care (POC) settings, focusing on market trends, drivers, opportunities, and competitive ...

The Korea Institute of Machinery and Materials (KIMM) has developed a compact, rapid pretreatment system capable of ...

In order to ensure the safety and efficacy of medical devices entering its Member States, the European Union (EU) has ...

In vitro diagnostics (IVDs ... "Being in the top 5 notified bodies for medical device certification, we offer extensive expertise and technical competence. Our global team of auditors, technical ...