Precision HealthTech Ltd

Primary accountability for MDR Art 15(3)(b)–(e): ensuring the EU DoC is drawn up and kept current (b); PMS obligations are met (c); vigilance/reporting under Arts 87–91 are fulfilled (d); and the statement of compliance for investigational devices per Annex XV, Ch II, §4.1 is issued (e). Also ensuring QMS regulatory compliance with MDR, UK MDR 2002 (as amended) and other applicable regulations.

Primary accountability for the technical documentation element of MDR Art 15(3)(b): ensuring the technical documentation is drawn up and kept current. Includes ensuring device design and development comply with MDR and applicable standards; the technical documentation reflects device design and performance; V&V activities are conducted and documented; conformity assessment and regulatory submissions are supported; and design outputs align with regulatory requirements.

Primary accountability for MDR Art 15(3)(a): ensuring device conformity is appropriately checked, in accordance with the QMS, before release. Includes ensuring manufacturing activities comply with QMS and regulatory requirements; production processes are controlled and validated where required; incoming inspection, storage and distribution meet defined requirements; traceability, batch control and product release are compliant; and supporting supplier control and critical supplier oversight.