On 10 February 2023, EVERBIZ was honoured to be invited by Danaher’s Cepheid to deliver EU IVDR training to its regulatory affairs department.
At the training, our trainer drew on many years of IVD industry experience to introduce the background and fundamentals of the IVDR, and analysed step by step the risk classification of IVD products, conformity assessment routes, technical documentation structure, quality system requirements and company strategies, outlining the regulatory framework. Practical cases were used to show companies how to respond.
Danaher Corporation
Danaher (NYSE: DHR) has a market capitalisation of about USD 200 billion, revenue of more than USD 29 billion and net profit of USD 6.2 billion, and is known as the “king of industrial M&A”. In the nearly 40 years since its founding in 1984, Danaher has achieved compound annual growth of 19% in earnings per share and 23% in its share price. Danaher recently reported its 2021 results, with full-year revenue of USD 29.453 billion, up 32% on 2020. To date, Danaher owns more than 20 companies with about 80,000 employees, operating as a diversified global team based on the well-known Danaher Business System (DBS).
Cepheid joined Danaher’s diagnostics platform most recently (in 2016). Founded in 1996, it is a leader in molecular diagnostics, dedicated to the research and production of rapid clinical molecular diagnostic products.