At Tame-Care, mastery of standards and technical references is a cornerstone of our expertise in active medical devices.
From the design phase onward, we integrate international requirements to ensure safety, performance, regulatory compliance, and industrial reliability. This approach enables us to anticipate risks, secure certification, and optimize the industrialization of your products.
At Tame-Care, we integrate all key medical industry standards from the design phase to ensure the safety, performance, and compliance of your devices. Our expertise covers major standards: IEC 60601 for electronics, IEC 62304 for software, ISO 14971 for risk management, as well as environmental, radio, and industrialization requirements.
This comprehensive expertise secures your certifications, reduces the risk of non-compliance, and accelerates industrialization. The result: reliable, compliant devices ready for a smooth market launch, both in Europe and internationally.
We apply the IEC 60601 standard to ensure the electrical safety and essential performance of your devices:
IEC 60601-1: electrical safety and electronic architecture
IEC 60601-1-2: electromagnetic compatibility (EMC)
Collateral standards: ergonomics (60601-1-6), alarm systems (60601-1-8), and specific standards by specialty (60601-2-xx)
Our teams anticipate laboratory tests and optimize prototypes to secure compliance from the earliest stages.
Software development is at the core of many medical devices. We apply the following international standards:
This expertise ensures reliable, safe, and regulatory-compliant software systems, while also facilitating the preparation of technical documentation and audits.
Risk management is a key priority. We apply:
This integrated approach ensures product safety, strengthens MDR technical documentation, and delivers an optimal user experience.
We ensure compliance with environmental standards and the requirements applicable to electronic equipment:
RoHS, REACH, WEEE: chemical safety and waste management.
RED Directive and ETSI standards: radio compliance for connected devices (Wi-Fi, Bluetooth).
This expertise ensures the safe commercialization of your products in European and international markets.
To ensure production reproducibility and robustness, we apply:
IQ / OQ / PQ: equipment and process validation.
GAMP 5: best practices for automated systems and test benches.
IEC 62402: electronic obsolescence management and technical continuity.
These methods reduce the risk of production deviations and secure the industrial scale-up.
