Medical Devices

Medical Devices are important health devices, which encompass a wide range of products. They are intended by their manufacturer to be used for purposes common to medicinal products, such as preventing, diagnosing or treating human diseases. They must achieve their ends through mechanisms that do not translate into pharmacological, metabolic or immunological actions, so they are distinguished from medicinal products.

ZEMIR PHARMA CONSULTING provides a complete service in order to verify that medical devices comply with the most up-to-date legal requirements and that they have the necessary conditions to be marketed.

• Medical devices classification support
• Preparation of the technical documentation under Annex II of the MDR
• Labelling and instructions for use elaboration and review
• Medical devices registration
• EUDAMED management
• ANF (National Association of Pharmacies) registration
• Instruction of processes for obtaining CE marking
• Advertising material review
• Vigilance
• Quality management system implementation and maintenance
• Responsible person support
• Person responsible for regulatory compliance