Web Summary
Q1: What is the address of Devyser AB?
A1: The company is based in Stockholm, Sweden with eight in-house sales offices in Europe and the US.
Q2: What products does Devyser develop, manufacture, and sell?
A2: Devyser develops, manufactures, and sells diagnostic solutions and analysis services to clinical laboratories in more than 65 countries. Their products are used for advanced genetic testing in various fields such as hereditary disease, oncology, and transplant.
Q3: What is the industry of Devyser AB?
A3: Devyser operates in the biotechnology and diagnostics industry, specifically in the field of genetic testing and analysis services.
Q4: What services does Devyser offer to its customers?
A4: In addition to developing and selling diagnostic solutions, Devyser also provides analysis services to clinical laboratories. They aim to simplify genetic testing processes, improve sample throughput, minimize hands-on time, and deliver rapid results.
Q5: What is the goal of Devyser's business?
A5: The company's primary goal is for every patient to receive a correct diagnosis in the shortest possible time. Sustainability is also a central part of their business, which is essential for long-term value creation.
Q6: When was Devyser AB founded?
A6: Devyser was founded in 2004.
Q7: What regulatory approval has Devyser received for its RHD product?
A7: In 2024, Devyser received IVDR (In Vitro Diagnostic Regulation) approval for its non-invasive fetal RHD screening product, marking the first approval of a Class D product under the new European regulation.
Q8: How does Devyser's quality management system relate to the IVDR?
A8: In 2022, Devyser's quality management system was certified according to the IVDR, and since then, several of the company's products have been certified according to the IVDR.