QUALITY POLICY

Fempharma is dedicated to designing, developing, and manufacturing medical devices and food supplements in the field of women’s health that consistently meet customer expectations and applicable regulatory requirements.

Fempharma operates as the legal manufacturer of its medical devices. The company is also registered in EUDAMED as a System and Procedure Pack Producer (SPPP) under Article 22 of Regulation (EU) 2017/745. This registration is maintained for potential future activities, which will be subject to applicable regulatory requirements and appropriate quality management controls before implementation.

Our commitment extends to ensuring the safety, performance, and regulatory compliance of our products and achieving customer satisfaction.

We achieve this through the implementation of an effective Quality Management System and adherence to applicable manufacturing and hygiene requirements, in alignment with relevant EU legislation, standards, and regulatory guidance.

Fempharma is committed to maintaining the effectiveness of its Quality Management System by:
• Establishing and monitoring measurable quality objectives that prioritize product quality, regulatory compliance, operational excellence, and customer satisfaction.
• Ensuring that personnel are competent through appropriate training and the provision of adequate resources.
• Regularly reviewing and improving the Quality Management System to maintain its suitability and effectiveness.
• Applying proactive risk management and maintaining effective communication with relevant stakeholders.
• Maintaining appropriate oversight and control of outsourced manufacturing processes. Fempharma is also committed to ethical conduct, sustainability, and environmental responsibility in its operations.

Dr Peter Bartal, CEO
August 1st, 2026

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