ScandiDos achieves EU Medical Device Regulation certification for the Delta4 Phantom+ product line
ScandiDos, a leading provider of patient-specific quality assurance solutions, has attained certification under the European Union Medical Device Regulation (MDR) for its quality system and Delta4 Phantom+ product line. The EU-MDR is one of the world's most robust health tech regulations, and it plays a vital role in ensuring medical devices meet the highest standards.
The MDR certification aims to enhance the safety and performance of medical devices within the EU, ensuring a high level of protection for patients and users. It imposes strict requirements on manufacturers regarding medical device design, manufacturing, and testing.
Receiving the EU's MDR certification underscores that ScandiDos' products consistently meet the highest standards, showcasing our dedication to elevating patient safety. The meticulous certification process is a testament to ScandiDos' overarching mission – to lead the industry by delivering cutting-edge solutions that set the benchmark for patient quality assurance (QA).
“Our successful compliance with the EU MDR underscores our unwavering commitment to delivering the highest quality patient QA solutions. This milestone reflects our team's dedication to meeting and exceeding regulatory standards for the benefit of patients worldwide,” says Gustaf Piehl, CEO and President, ScandiDos.