Quality
Regulatory requirements serving your electronic medical devices
At Tame-Care, quality and compliance are not just regulatory obligations: they are levers for performance and controlled market launch of your electronic medical devices.
We put our expertise at the service of the design, development, and industrialization of safe, reliable hardware solutions that meet the strictest requirements of the medical sector.
From mastering international standards to European and global regulatory requirements, Tame-Care supports your teams throughout the lifecycle of your devices, helping secure your projects, accelerate market access, and strengthen the confidence of authorities, healthcare professionals, and patients.
A comprehensive approach to qualitys to life
With a cross-functional vision of quality, safety, and regulation, Tame-Care helps healthcare stakeholders to:
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secure their projects,
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accelerate time-to-market,
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ensure the compliance of their medical devices.
ISO 13485 – Quality management for medical devices
ISO 13485 defines the requirements for quality management systems for medical devices.
At Tame-Care, we integrate the principles of ISO 13485 to ensure:
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process control throughout the product lifecycle,
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traceability and risk management,
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regulatory compliance of medical devices.
ISO 27001 – Information and health data security
Data protection is a major challenge in the healthcare sector.
ISO 27001 provides a framework for implementing an information security management system.
Tame-Care relies on this standard to ensure:
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confidentiality, integrity, and availability of data,
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cyber risk management,
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protection of health data and critical systems.
Technical standards
Tame-Care supports medical device manufacturers by integrating all relevant industry standards and technical references from the design stage.
From electronics to software, including risk management, environmental compliance, and industrialization, we master the key standards.
This comprehensive approach secures certification, reduces non-compliance risks, and guarantees reliable, high-performance products ready for smooth market launch, both in Europe and internationally.
CE marking – Regulatory compliance in Europe
CE marking certifies that a medical device meets the requirements of Regulation (EU) 2017/745 (MDR).
Tame-Care assists its clients with:
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preparation of the technical file,
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management of quality and regulatory requirements,
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bringing medical devices into compliance.
FDA marking – Access to the U.S. market
For the U.S. market, the FDA (Food and Drug Administration) imposes specific requirements for quality, safety, and performance.
Tame-Care addresses FDA requirements for:
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medical devices,
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quality documentation,
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compliance with U.S. standards.
