TRONICO
Expert in critical medical devices
TRONICO, founded in 1973 and based in Vendée (France), is a key player in the field of Electronic Manufacturing Services (EMS). With over 50 years of experience, TRONICO provides a comprehensive range of electronic manufacturing services, from industrialization to mass production of electronic devices for diverse sectors such as aerospace, defense, energy, and healthcare.
Since joining the Agôn Electronics group in 2023, TRONICO has become the group’s specialist in the manufacturing of critical medical devices. The company is equipped with state-of-the-art facilities and highly qualified personnel, allowing it to meet the stringent requirements of Class IIA, IIB, III, and Active Implantable Medical Devices (AIMD).
Its close geographic proximity to the teams at Tame-Care, Tame-Test, and the experts at the Tame-Component laboratory further enhances its responsiveness and ability to deliver tailor-made solutions for the medical sector. This proximity enables seamless collaboration and efficient project management, offering clients optimal synergy between the group’s entities for the development of the most complex medical devices.
Contact
26 Rue du Bocage
85660 Saint-Philbert-de-Bouaine
+33 (0)2 51 41 91 35
[email protected]
Their expertise
Industrialisation
TRONICO transforms concepts into reliable industrial products that comply with international standards (ISO 13485, FDA, MDR).
Its expertise in design, manufacturing, risk analysis, and industrial qualification ensures cost control, risk reduction, and accelerated time-to-market.
Manufacturing
TRONICO assembles complex electronic boards in ISO 13485-certified facilities, ensuring traceability, reliability, and repeatability.
The company masters both SMT and through-hole technologies for low to medium volume production runs, meeting the highest quality standards.
Integration
TRONICO handles the assembly of electronic boards, electronic and mechatronic systems, all the way to the final integration of devices.
Its three ISO 7 cleanrooms enable production in a controlled environment, ensuring the cleanliness, performance, and reliability required for critical medical applications.
Testing and quality control
TRONICO places testing at the core of its production, implementing strategies tailored to the medical sector: AOI, X-ray, ICT, and functional testing.
Each device is inspected at every stage, with full traceability, to ensure compliance, safety, and reliability.
The expert in critical medical devices
TRONICO supports manufacturers of critical medical devices—implantable, diagnostic, or monitoring—by offering comprehensive expertise from industrialization to mass production.
With mastery of standards, industrial excellence, and electronic innovation, TRONICO is the trusted partner for devices where no errors are tolerated.
Certifications
At TRONICO, quality, safety, and compliance are at the core of our priorities in the medical device field.
The company is certified according to the most demanding industry standards.
The ISO 13485 certification is a cornerstone for TRONICO, ensuring quality, traceability, and risk management throughout the manufacturing of medical devices. It demonstrates compliance with the highest standards in quality management, delivering products that are compliant, safe, and reliable, in line with regulatory requirements and market expectations.
The ISO 9001 certification reflects TRONICO’s commitment to rigorous and continuous quality management at every stage of its processes. It ensures systematic production control, continuous performance improvement, and a proactive response to customer requirements, thereby enhancing the reliability and compliance of the devices manufactured.
The ISO 27001 certification reflects TRONICO’s commitment to protecting sensitive data and critical information related to medical devices. It ensures the implementation of robust security measures, proactive risk management, and effective incident response protocols, thereby safeguarding the confidentiality, integrity, and availability of data throughout the product lifecycle.
Why choose TRONICO?
With over 50 years of experience, TRONICO is a trusted subcontractor in the medical device sector, recognized for its industrial expertise, mastery of complex processes, and high quality standards.
The company offers end-to-end support, from industrialization to mass production, within controlled environments (ISO 7 cleanrooms), ensuring reliability, traceability, and regulatory compliance.
Thanks to its skills in manufacturing Class II, III, and implantable active devices, TRONICO adapts to the most critical needs of the medical market, positioning itself as a strategic partner with strong technological added value.