TRONICO, electronic supplier to the medical sector
Stimulated in recent years by the boom in electronic technologies, the medical sector has continued to innovate in order to develop new medical devices aimed at saving lives, compensating for disability and improving patient comfort.
As a leading industrial partner, TRONICO supports its customers at every stage of their project. From design, through regulatory procedures, to series production, TRONICO brings to life numerous projects for critical electronic medical devices: IIa, IIB, III, DM DIV.
The men and women of TRONICO are fully committed and motivated by the technological challenges they face, mobilising their skills on a daily basis to meet the specific needs of their customers.
TRONICO's expertise in the medical market
Electronic design
With its experienced, multidisciplinary design office of 100 people, TRONICO provides the engineering and expertise essential to the design project. The experience it has acquired in numerous projects enables it to master the essential technological building blocks: connectivity, biocompatibility, cybersecurity, etc.
Based on the specifications, TRONICO’s teams carry out the following developments:
- Electronics
- Software
- Mechanics
With a laboratory specialising in electronic components, TRONICO is also able to support its customers in their choice and qualification of electronic components.
In short, TRONICO has all the expertise needed to design any type of medical device.
Industrialisation
Industrialisation looks for and analyses reliable and sustainable solutions to optimise the manufacture of electronic assemblies. TRONICO’s industrialisation service facilitates and supports the transition from prototypes to series production. This industrialisation phase starts at the very beginning of the project in order to optimise production costs in the short, medium and long term.
The first phase consists of analysing the design of the product and the electronics in order to improve manufacturing. The second is based on the construction and development of processes to meet the most demanding applications.
- Design for procurement: securing supplies of raw materials
- Design for manufacturing: optimising manufacturing and integration
- Design for test: adapting the product for testing
- Design to cost: improve the unit cost of the product
- Design of new processes
Industrial expertise
TRONICO’s experience in the design and manufacture of critical systems has always ensured a high level of reliability and quality.
TRONICO has developed its industrial assets, its processes and the skills of its teams to optimise its medical device manufacturing and assembly services.
Equipment: 3 iso 7 clean rooms, pick and place machines, vacuum reflow oven, 3 d cnc vision measurement systems, test equipment (x-ray, aoi, flying probes, insitu, jtag, functional, etc.).
Specific processes: complex assembly, custom moulding, parylene coating, gluing, varnishing, resin coating, coating, laser marking, PCB milling, etc.
Maintaining operational conditions
Product life management is essential, because these days electronics become obsolete very quickly. The risks associated with obsolescence are numerous and can have a major impact:
- logistical disruption due to the obsolescence of a component
- changes in technological characteristics leading to malfunctions
- increased prices and lead times for end-of-life components
- additional costs generated by these difficulties
TRONICO, through its electronics expertise laboratory, offers advanced obsolescence management solutions:
- Monitoring and alerting in the event of obsolescence risk for an electronic component
- Secure storage
- Detection and supply of counterfeit components
- Repairs, up to life support
- Reverse engineering
Test strategy and test benches
The quality, reliability and conformity of medical devices depend in part on the tests they undergo.
TRONICO develops, manufactures and maintains a complete range of test equipment for electronic boards, sub-assemblies and integrated systems for the medical sector, based on a test specification from its own design office or that of its customers.
- Dedicated team of test experts
- Customised, made-to-measure test benches.
- Manual, semi-automatic or fully automatic test equipment
Regulatory affairs
Regulation is a critical factor in many medical device projects. Although SMEs and ETIs have a good grasp of these regulatory aspects, start-ups are often at a loss when it comes to dealing with these issues. To help them, TRONICO offers its customers regulatory support to help them determine…
- Classification of your DM (risk class, EMDN code, MDS/MDN/MDT/MDA code)
- Choice of Notified Body
- Responses to general safety and performance requirements
- Clinical evaluation file
- Literature review (state of the art)
- Fitness for use file
- Biological risk assessment
- Toxicological risk analysis (excluding laboratory analysis costs)
- PMCF plan
- PMS Plan
TRONICO certifications in the medical market
ISO 13485
ISO 13485 is a voluntary quality certification standard developed for the medical devices sector. These requirements “may be used by an organisation for the design and development, production, installation and associated services of medical devices, as well as for the design, development and provision of related services”.
This certification is a guarantee of the ability to regularly supply medical devices and services that comply with customer requirements and applicable regulatory requirements.
ISO 9001
The standard is based on a number of quality management principles, including a strong customer focus, management motivation and commitment, a process approach and continuous improvement. By using ISO 9001, you can ensure that your customers receive consistent, high-quality products and services, which in turn will have a positive impact on your business.