Manufacturing your medical device
The strength of an industrial group
Tame-Care supports you throughout the manufacturing transfer phase, from creating the documentation to validation through pre-series production, and manages the full production process for your medical device.
As part of the AGÔN Electronics group, we leverage the strength of an entire industrial network, particularly its expertise in the production of active medical devices. This enables us to handle the production of the active medical devices we design for you.
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Our Support
Integrated Manufacturing Solutions
Tame-Care benefits from the expertise of renowned French EMS subcontractors in critical medical device production: TRONICO, FEDD, and Phénix Electronique.
With three ISO 13485-certified production sites, including one FDA-registered site, we are equipped to manufacture even the most complex medical devices.
State-of-the-Art EMS Facilities
These industrial partners have invested in their assets, processes, and team skills to optimize their medical device manufacturing and assembly services.
Equipment: ISO 7 cleanrooms, SMT lines, vacuum reflow ovens, 3D measurement systems, testing equipment, and more.
Specialized Processes: Complex assembly, custom molding, parylene coating, bonding, varnishing, potting, encapsulation, laser marking, PCB milling, and more.
Quality Control at Every Stage
Various tests on products and product batches are systematically performed to ensure compliance with CE and FDA regulations. Comprehensive quality control processes are divided into three stages: IQC, IPQC, and FQC.
- Raw material testing
- Regular equipment testing
- Technician training and development
- Isolation of non-conforming products
- Product testing and validation
- Corrective and Preventive Action (CAPA) management
- Risk management
Lean Manufacturing and Continuous Improvement
Lean Manufacturing and Continuous Improvement
Our EMS partners apply Lean Manufacturing methodologies and continuous improvement strategies to help reduce costs and enhance yields during development and commercial production ramps. Lean tools include:
- DMAIC problem-solving
- Flow mapping
- Cellular manufacturing
- Line balancing
- One-piece flow
- Point-of-use Kanban
- Real-time statistical process control
Our Commitments
Quality
With a robust quality management system certified to ISO 13485 and our process-oriented philosophy, we ensure high-quality production of your medical devices.
Flexibility
Our clients value our flexibility. Our teams and manufacturing capabilities allow us to quickly adapt to our clients’ needs, meaning we can easily adjust our scheduling to switch from one product to another, align with our clients’ timelines, and rapidly scale up production when necessary.
From printed circuit board assembly to full assembly of medical devices
High flexibility and rapid scalability options.
Budget Compliance
Staying within your project budget and delivering it on time and in full is part of our commitment. Close collaboration between teams involved in supply chain management, R&D, and production ensures streamlined and optimized processes across our organization. Operational excellence is one of our top priorities to meet your expectations.
FAQ
Do you handle series production?
Yes, Tame-Care manages series production of active medical devices, ensuring reliability, quality, and regulatory compliance.
We rely on the production units of the group: Tronico, FEDD, and Phénix Électronique. These sites handle assembly, electronic and mechanical integration, and final testing for each batch.
This setup allows us to meet both small-series pilot projects and full industrial lots, maintaining consistent quality and scalable production capacity.
Can you produce sterile or sterilizable devices?
Tame-Care supports the design and production of sterile or sterilizable medical devices, leveraging specialized facilities and strong expertise in controlled environments.
We have three cleanrooms within TRONICO, enabling assembly and packaging of sensitive devices, as well as handling critical components, particularly for invasive or implantable devices.
Tame-Care also addresses all sterility requirements: design compatibility with sterilization processes (ETO, gamma, steam, plasma, etc.), material selection, biocompatibility validation (ISO 10993), and development of appropriate packaging strategies.
This comprehensive approach ensures clients receive compliant, high-performing devices ready for sterilization, in line with MDR and FDA requirements.
How do you ensure regulatory compliance during production?
At Tame-Care, regulatory compliance is integrated at every stage of active medical device production.
- Our production units, Tronico and FEDD, are ISO 13485 certified and strictly adhere to applicable standards and regulatory requirements.
- Each batch undergoes quality controls, full traceability, and systematic verification, ensuring every device meets regulatory standards.
- Our processes also include documentation and regulatory follow-up, facilitating compliance during audits and market release.
How do you handle product returns and complaints?
At Tame-Care, product returns and complaints are managed through a structured and rigorous process, ensuring speed, transparency, and regulatory compliance.
Each returned product is immediately and thoroughly analyzed to identify the root cause, whether related to a component, software, usage, or manufacturing. Thanks to our ISO 13485-certified processes, every batch and component is fully traceable, simplifying incident investigation and resolution.
Corrective and preventive actions (CAPA) are implemented to prevent recurrence and reinforce device reliability. Communication with clients is continuous, providing technical support for replacement, repair, or product updates.
If necessary, technical documents and quality processes are updated to maintain full compliance with MDR and FDA requirements.