Advanced Oncotherapy PLC, a specialist developer of proton therapy technologies that treat cancer patients, has successfully obtained ISO 13485:2016 certification for its LIGHT proton therapy system. It is expected to be the first commercially available linear proton accelerator for radiotherapy treatment.
Following a successful audit by LRQA, certification to the internationally recognised standard was awarded. As a result, shares in Advanced Oncotherapy PLC rose in Monday’s mid-morning trading window demonstrating what an important milestone it was for the company. Director of Regulatory Affairs at Advanced Oncotherapy PLC, DR Michel Baelen said compliance with the quality management system (QMS) standard illustrated the importance the firm places on the quality of its products, as well as “dedication to ensuring that the infrastructure to develop and manufacture our product is safe, effective and reliable”.
ISO 13485:2016 is the international standard that defines quality management system requirements for manufacturers of medical devices and organisations that support medical device manufacturers. It underpins the manufacturers’ duty of ensuring devices consistently meet customer and applicable regulatory requirements.
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