CE marking: controlled design and production
Tame-Care ensures the development and manufacturing of your active medical devices to guarantee their European compliance
At Tame-Care, we support medical device manufacturers through all the steps required to obtain CE marking, ensuring compliance with European requirements and the safe, accelerated market launch of their products.
Our expertise covers design, industrialization, production, and regulatory support, integrating best practices and applicable standards for active medical devices from the very start.
Your medical devices ready for the European market
At Tame-Care, we safeguard your active medical devices from design through production, integrating MDR standards and requirements from the outset to facilitate CE marking.
Thanks to our expertise in industrialization, traceability, and quality control, combined with the full regulatory support from Cisteo Medical, we turn your prototypes into reliable, safe, and compliant devices, ready for a fast and secure market launch.
Our commitments
Design compliant with European requirements
From the earliest stages of development, we apply the essential requirements of Regulation (EU) 2017/745 – MDR:
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Definition and traceability of product requirements
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Comprehensive risk analysis according to ISO 14971
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Ergonomic design and usability safety according to IEC 62366
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Software development compliant with IEC 62304 / IEC 82304-1
This integrated approach facilitates the preparation of the CE technical file and reduces the risk of delays or non-compliance during audits.
Controlled industrialization and production
Our teams ensure that every device is manufactured in compliance with regulatory requirements and good practices:
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Process validation (IQ / OQ / PQ) to guarantee reproducibility and reliability.
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Equipment qualification and rigorous quality control at every stage.
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Supply chain management and supplier qualification for critical components.
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Implementation of traceability systems and documentation in accordance with CE requirements.
Thanks to this approach, we turn prototypes into products ready for the European market, maintaining high standards of quality and safety.
Technical support for CE marking
At Tame-Care, we support our clients in producing devices that comply with CE marking requirements, ensuring robust industrial processes and consistent quality:
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Implementation of industrial processes and quality systems aligned with MDR requirements (ISO 13485).
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Complete traceability of components, batches, and devices to facilitate the preparation of the CE technical file by our clients.
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Integration of best practices in quality control and monitoring to prepare for production and audits.
- Flexibility to adapt processes to regulatory changes, ensuring product compliance.
Our role is to secure the production and industrialization of your medical devices while easing the work of regulatory teams and reducing CE marking–related risks.
