The medical market includes all companies involved in research, development, production and marketing in the health sector: pharmaceutical laboratories, medical devices, in vitro diagnostics and digital companies.
That market includes
- 260 pharmaceutical companies
- 1343 medical device manufacturers, 92% of which are SMEs.
- 100 in vitro diagnostic companies, 90% of which are SMEs.
- Numerous start-ups that innovate and drive the sector upwards
- 450 very small biotechs and medtechs. Those are often the result of French research.
The market's challenges
The sector is facing global growth in demand. Companies must continually innovate to remain competitive. Furthermore, foreign competition is fierce and means that companies must be able to adapt to an increasingly personalised field of medicine and to ever tighter regulatory requirements.
The medical sector is highly regulated and controlled, most prices are set by the State. The position of companies on the world market therefore depends on maintaining a high level of technological expertise and strengthening the competitiveness of national players.
Tomorrow's major challenges for this economic sector are linked to multiple medical technologies, more innovative diagnostics and therapies and easier-to-extract data, especially thanks to artificial and connected objects.
Tame-Component's expertise in the health sector
Tame-Component has developed mainly in the medical field over the last few years. TRONICO Healthcare and TAME-CARE have required our service's development and a seamless methodology to meet the sector's requirements.
With its recognised expertise in so-called critical medical devices (class II, III, AIMD, etc.), Tame-Component brings its know-how to component qualification and characterisation, assistance in solving electronic problems (components, boards, systems) and the management and treatment of obsolescence.
Its expertise in the design, development and production of medical devices via the TRONICO healthcare teams, its "laboratory" skills acquired in the most demanding sectors, as well as its three ISO7 clean rooms dedicated to implantable medical devices, enable it to provide you with top-of-the-range services whether you are a/an
- Manufacturer of medical devices
- Component manufacturer or supplier
Tame-Component certifications and accreditations
Tame-Component designs and manufactures test benches for the medical sector which requires, in addition to compliance with ISO standards, guarantees related to confidentiality.
Tame-Component ensures that all its equipment
- complies with low voltage directives
- has CE marking
- has UL marking
- complies with the machine directive
In addition, if the equipment is a medical device accessory, Tame-Component ensures compliance with regulatory requirements (class A, B or C)
ISO 13485 is an international quality management standard that allows the implementation of regulatory requirements applicable to medical devices and associated services (DIR 93/42/EEC, DIR 98/79/EC, DIR 2007/47/EEC and DIR 90/385/EEC).
In the absence of medical grade components, many medical device manufacturers use automotive grade components.
Tame-Component is involved, through the RECOME project, in the writing of a standard dedicated to the reliability and safety of highly critical electronic medical devices.
To be of automotive grade, components must pass qualification tests. Qualification is carried out batch by batch to ensure the absence of process deviations that haven’t been identified by the manufacturer.