Our expertise, at the service of your medical devices
From concept to production, comprehensive and controlled support at every stage of product development.
Comprehensive Support, from Concept to Production
At Tame-Care, we believe that an effective and innovative medical device is born from a rigorous, structured process, always focused on the real needs of end users.
That’s why we have structured our support around five key areas of expertise covering the entire product development cycle, from the initial brainstorming phase to industrial production.
A synergy of expertise to power your innovations
Our strength lies in integrating these five areas of expertise within a single ecosystem.
This holistic approach allows us to ensure seamless continuity between each stage, enhance responsiveness, and provide our clients with a clear, reliable, and scalable vision of their project.
Definition
Every project begins with a thorough definition phase. We take the time to listen, understand needs, and consider regulatory, technical, and economic constraints to lay a solid foundation.
This phase translates ideas into clear and realistic specifications, aligned with market challenges and user requirements.
We engage our multidisciplinary team to co-create a shared vision of the project.
Design
Next comes the design of the device, a phase where innovation takes shape.
Our engineers, designers, and healthcare experts collaborate to develop a solution that is efficient, ergonomic, and compliant with current standards.
Prototyping
Prototyping plays a central role in our approach. It validates technical choices, tests real-world usability, and anticipates optimizations needed before production.
We create high-precision functional prototypes quickly, ensuring informed decision-making and minimizing downstream errors.
Industrialization
Once the prototype is validated, we move into the industrialization phase. This involves adapting the product for mass production while maintaining quality, performance, and compliance.
Our teams work on material selection, tooling design, process definition, and validation of initial production runs.
This phase is crucial to guarantee the robustness and repeatability of the final product.
Manufacturing
Tame-Care, a subsidiary of the industrial group AGÔN Electronics, supports you in transferring your medical device to manufacturing, from dossier creation to validation through pre-series production, ensuring complete project management of production.
Leveraging the group’s expertise in active medical devices, we are capable of manufacturing the devices we have designed for you.
FAQ
Who are you?
Tame-Care specializes in the design, industrialization, and manufacturing of active medical devices on behalf of third parties.
We support our clients throughout the entire device lifecycle, from concept definition to series production.
Our expertise is based on:
- Complete engineering: electronics, mechanics, and embedded software.
- Mastery of the most demanding medical standards (ISO 13485, MDR, IEC 62304, etc.).
- The ability to design innovative, reliable, and safe devices, even for high-criticality applications.
- Industrial resources of the AGÔN Electronics group, enabling large-scale production with high quality standards.
Tame-Care is the ideal partner to transform your ideas into reliable, high-performance, and compliant active medical devices.
What types of medical devices do you handle?
At Tame-Care, we specialize exclusively in active medical devices, integrating mechanics, electronics, and embedded software.
We work across all regulatory classes: IIa, IIb, III, as well as AIMD (active implantable devices) and IVD (in vitro diagnostic devices).
Our expertise includes:
- Portable or embedded electronic devices
- Active implantable systems (neurostimulation, sensors, pumps, etc.)
- Connected and communicating devices (RF, BLE, NFC, etc.)
- Critical electronic architectures and embedded software (IEC 62304)
- Automated or electronic in vitro diagnostic instruments
What expertise do you offer?
Tame-Care can develop an active medical device from A to Z, handling the entire product lifecycle:
- Consulting and concept definition: needs analysis, technology selection, and regulatory strategy
- Full design: electronics, mechanics, and embedded software
- Reliability assurance: component analysis and full validation to ensure robustness and quality
- Prototyping and testing: proof-of-concepts, functional and qualified prototypes, technical validations
- Industrialization and production: design optimization for manufacturing, ISO 13485-certified assembly, traceability, and quality control
- Regulatory support: technical file preparation, CE/FDA compliance, and post-production follow-up
- Supply chain and sustainability: secure sourcing, supplier management, obsolescence anticipation, and operational maintenance
From idea to finished product, Tame-Care transforms concepts into reliable, safe, market-ready medical devices.
What are your added values?
At Tame-Care, we support the development of complex and high-criticality active medical devices by combining technical expertise, innovation, and mastery of series production.
Our integrated approach turns ambitious ideas into reliable, safe devices compliant with the strictest standards.
Our strengths include:
- Mastery of critical devices: implantable AIMDs, electronic IVDs, and Class IIa, IIb, III devices, with expertise in components, embedded software, and complex electronic architectures
- Integrated design and production: from design to industrialization and ISO 13485-certified production, optimizing quality, reducing time-to-market, and facilitating commercialization
- Advanced reliability: customized test strategies and benches, electronic component laboratory, full validation to ensure performance, robustness, and durability
Who do you work with?
Tame-Care supports a wide range of medical industry stakeholders by providing tailored assistance in design, industrialization, and manufacturing, as well as technical and regulatory support and flexible production adapted to desired volumes.
We cover all stages, from prototyping to production, for:
- Medical startups
- SMEs, mid-sized companies, and large medical device manufacturers
- Laboratories, hospitals, and clinical centers
Can you work on confidential projects?
Yes, Tame-Care works on confidential and strategic projects, following strict confidentiality and security processes to protect sensitive information, prototypes, and client data.
We ensure:
- Full protection of intellectual property and innovations
- Signing of non-disclosure agreements (NDAs) tailored to each project
- Secure premises and digital exchanges
This structure allows us to collaborate with confidence on critical or innovative medical devices, even in highly sensitive contexts.