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Services
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Medical Devices Support

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Medical Devices Support

[/vc_column_text][/vc_column][vc_column column_padding=”padding-2-percent” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/2″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]Clinres Farmacija offers a wide range of services in the field of medical devices. Given the diversity of this area, our service packages are tailored to meet the various needs and requirements of companies.

Our services include:

  • Regulatory compliance: We assist in ensuring compliance with all relevant regulations and standards at the national level (e.g. compliance with MDR ((EU) 2017/745), IVDR ((EU) 2017/746), and ISO 13485 for quality management systems).
  • Clinical evaluation (CEP and CER): We prepare the Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in compliance with MDR (EU) 2017/745, including literature review, data appraisal, and regulatory strategy support.
  • Translation preparation: We provide professional translations of instructions for use, labelling, and other important documents in accordance with legal requirements.
  • Packaging review: We carefully review the packaging and labelling of medical devices to ensure compliance with regulatory requirements regarding the necessary labels and information.
  • Promotional material review: We ensure that promotional materials comply with all legal and regulatory guidelines.
  • Registration: We provide assistance with the registration of medical devices and the registration of business activities with the competent authority.
  • Consulting: We offer expert consulting in the field of medical device regulation, including interpretation of regulations, market entry strategies, and solving regulatory issues.
  • Collaboration with regulatory authorities: We assist with communication and collaboration with regulatory bodies and ensure compliance with their requirements.
  • Vigilance: We provide support in meeting the requirements for reporting adverse events and complications to ensure post-market safety of the devices.
  • Operational procedures: We assist in preparing operational procedures related to company activities, processes, and workflows.
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