PMD ensures all design, market surveillance, and operational procedures are to the highest standard and the company is independently audited by our notified body SGS on at least an annual basis. PMD also conforms to harmonised standards for the on-going design and research activities such as Risk Management ISO 14971, Medical Device Usability IEC 62366, Medical Device Software ISO 62304, and Medical Device Clinical Investigation ISO 14155, to mention but a few.
PMD, led by the regulatory and quality team, is also in compliance with US FDA 21 CFR 820 quality system requirements and has built into RespiraSense, and subsequent concept documents, FDA specific product development requirements. During the course of this project, and afterward, PMD plans to publish its clinical results through medical journals, for example British Journal of Medicine (BJM), Resuscitation, Emergency Medicine, Critical Care, and European Journal of Respiratory Medicine. All papers will be published under Gold Access to ensure its accessibility can be maximised to the broadest audience in particular in cases where clinicians might not have an active subscription to all journals.