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Electronic systems for medical applications

Electronic systems for medical applications

Leaning on its 40 years of experience and its accreditation ISO 13485, TRONICO knows how to meet the specific needs, requirements and quality of the medical field.
In addition to its core EMS (Electronic Manufacturing Services) business, TRONICO has established itself as an ODM (Original Design Manufacturer) in the development of complex electronically dominant systems with high-added value.
Specialized in medical devices (non-invasive systems, diagnosis instruments, invasive systems and implants) TRONICO is capable of taking part in its customers’ project and of supporting them in risk management.

Certifications Medical

Electronic design

TRONICO develops class I, IIa and IIb medical devices: non-invasive devices, diagnosis instruments, invasive devices, surgical implants.

Product developments are made according to ISO 10993, ISO 14155, ISO 14971, EN 60601 and EN62304. A specific quality department is dedicated to ensure the respect of internal process and accreditations. TRONICO is able to handle the accreditation of its customer’s devices.

Experienced teams develop and analyse products to reach and maintain requirements regarding Safety & Reliability (RMAS: reliability, maintainability, availability, safety).

TRONICO’s engineers acquired specific knowledge in the following technical fields:

  • power conversion and storage
  • power electronics
  • network & communication
  • radio-frequency
  • numerical electronics/ FPGA/ µC
  • embedded software
  • rugged computers
  • high temperature
  • ...

In addition to its skill in terms of electronics and mechanical development, TRONICO has internal means for layout rooting as well as automatic test benches realization.

Electronic prototyping

As a partner in innovation projects, TRONICO offers two kinds of short time manufacturing thanks to a dedicated unit:

  • Proof of concept (POC) and mock-up
  • Prototypes

TRONICO is organized with a specific « prototype » team, which enables it to provide quick manufacturing capability. It provides an expertise regarding purchasing and manufacturing to guarantee reliable and sustainable solutions.

The « prototype » team leans on experienced workers dedicated to this task and led by a prototype coordinator which regroups and handles the customer’s needs and matches them according to industrial constraints.

This “prototype” team disposes of identical and independent production means.

Electronic industrialisation

The industrialisation process involves searching and analysing reliable and sustainable solutions to optimise circuit board manufacturing. Industrialisation service facilitates and handles the progress from prototypes to production runs. Industrialisation is integrated from the start of a project to optimize short, medium and long-term production costs.

Industrialisation optimises production and consists of the following elements:

  • Purchasing/supply FMECA*: used by TRONICO to handle the risks and obsolescence
  • Process FMECA*: used by TRONICO to handle processing risks
  • DfX:
    • DfM (Design for Manufacturing): analysis of  the manufacturability of the boards and their integration
    • DfT (Design for Test): defining and optimizing the test strategy
  • Design to cost: design methodology to optimise product cost

(*Failure Modes, Effects and Criticality Analysis).

Assembly and testing

TRONICO has more than 40 years’ experience in electronic products and PCB assembly. This specific know-how of electronic system manufacturing is used to realize extremely complex devices while guaranteeing high quality and traceability in compliance with the product requirements.

To do so, TRONICO leans on specific manufacturing means dedicated to electronic systems realization (SMD lines, wave soldering, X-ray, AOI…).

In addition to its manufacturing capability, TRONICO offers a full range of testing solutions (flying probes, ICT, thermal shocking, vibrations, functional testing…). Testing scope is elaborated to provide a permanent loop of improvement.

Thanks to its Nadcap accredited facility in Morocco, TRONICO is able to provide these solutions at a competitive price.

Best-cost manufacturing

Both manufacturing locations, St Philbert de Bouaine (France) and Tangier (Morocco) use the same process and equipment, both also have the same quality accreditation. The Tangier site is the first to be Nadcap certified on the African continent.

Depending on the customer’s needs and requirements, TRONICO is able to offer manufacturing in France and/or in Morocco.

Activity continuity is ensured thanks to the total compatibility of both locations.

Maintainability in Operational Conditions

To allow long term use of a product or an equipment (5 to 20 years, or even more), TRONICO offers global solutions. These solutions include:

Components engineering

TRONICO commits to continuous improvement and reliability of electronic components through its internal components testing laboratory accredited COFRAC. This global commitment leans on: