Anna M.

Quality Assurance and Regulatory Affairs Manager @Apollo Healthcare Technologies Ltd

Leeds, GB

Responsible for regulatory compliance and strategy across a range of Class I and IIa pressure area care products, including active medical devices with integrated electrical components.• Managed updates to technical documentation in line with MDR 2017/745, including Clinical Evaluation Reports (CERs), Risk Management Files (RMFs), and usability documentation.• Worked closely with product and engineering teams to ensure compliance with IEC 60601 (electrical safety), EN 62304 (software lifecycle), and ISO 14971 (risk management).• Oversaw the QMS upgrade to meet MDR requirements and led successful audits with the Notified Body.• Supported UDI implementation (GS1) and managed EUDAMED registration• Delivered in-house training on MDR-aligned procedures and maintained ongoing compliance across EU and global markets.• Acted as the main regulatory point of contact during certification processes and responded to technical queries with a practical, risk-based approach.