Quality
At Tame-Care, quality and compliance are not just regulatory obligations: they are drivers of performance and controlled time-to-market for 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 most stringent requirements of the medical sector.
From mastering international standards to addressing European and global regulatory requirements, Tame-Care supports your teams throughout the entire lifecycle of your devices, helping to secure your projects, accelerate market access, and strengthen the confidence of authorities, healthcare professionals, and patients.
A comprehensive approach to quality
Thanks to a cross-functional approach to quality, safety, and regulatory compliance, Tame-Care helps healthcare stakeholders to:
- secure their projects,
- accelerate time to market,
- ensure the compliance of their medical devices
ISO 13485 – Quality management for medical devices
The ISO 13485 standard defines the requirements for quality management systems specific to medical devices.
At Tame-Care, we integrate the principles of ISO 13485 to ensure:
- control of processes throughout the entire product lifecycle,
- traceability and risk management,
- regulatory compliance of medical devices.
ISO 27001 – Information security and healthcare data protection
Data protection is a major concern in the healthcare sector. The ISO 27001 standard provides a framework for implementing an information security management system.
At Tame-Care, we rely on this standard to ensure:
- the confidentiality, integrity, and availability of data,
- cyber risk management,
- the protection of healthcare data and critical systems.
Technical standards
Tame-Care supports medical device manufacturers by integrating, from the earliest design stages, all relevant industry standards and technical references.
From electronics to software, including risk management, environmental compliance, and industrialization, we master the key standards.
This comprehensive approach secures certification, reduces the risk of non-compliance, and ensures reliable, high-performance products that are ready for smooth market entry in Europe and internationally.
CE marking – Regulatory compliance in Europe
The CE marking certifies that a medical device complies with the requirements of Regulation (EU) 2017/745 (MDR).
Tame-Care supports its clients in:
- preparing the technical documentation file,
- managing quality and regulatory requirements,
- ensuring compliance of medical devices.
FDA clearance – Access to the U.S. market
For the U.S. market, the FDA (Food and Drug Administration) imposes specific requirements in terms of quality, safety, and performance.
Tame-Care takes FDA requirements into account for:
- medical devices,
- quality documentation,
- compliance with U.S. standards
