Design tailored for manufacturing
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.
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
Contact
Offers tailored to the different stages of your project
High value-added services
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.
