FEASIBILITY STUDY AND PROTOTYPING
Our clients’ ideas are the driving force that push us towards the research of innovative solutions in the field of electro-medicals. For this reason, Microlab Elettronica puts its experience in the fields of electronics, mechanics and software developing at the clients’ disposal; thus, we are able to assess carefully the clients’ needs and propose to them the most advantageous path for the achievement of the final objective.
Through an accurate feasibility study, our experts analyze the technical, organizational and economic aspects of the project, so that it is possible to highlight any critical points and possible solutions. As a consequence, we draft a document where the objectives, the requisites, the strategy to use, the actions to accomplish and the necessary budget to succeed in the project, are defined.
If the conclusions are positive, we proceed with the prototyping of the device, giving the clients the opportunity to see the final product first-hand and verify that the solutions adopted are in line with the initial expectations.
ENGINEERING FOR PRODUCTION
Engineering is the intermediate phase between the planning of a product and its mass-production. Starting from the prototype we make some corrections in order to improve the characteristics and look for ideal solutions that can facilitate the production process. Microlab Elettronica avail itself both of its own competences and of the habitual supplier networks to obtain the best result in view of specific problems.
HANDBOOK AND PATENT DRAFTING
In order to be commercialized, the electro-medical products need the declaration of compliance with the current regulations. The European legislation connotes that the devices are labeled “CE” combined with a CE declaration of compliance, as well as a use and maintenance manual in the language of the user; on the other hand, the devices that have to be commercialized in the United States, need the release of the FDA (Food and Drug Administration) certification.
The procedure to be followed in order to be acknowledged with these certifications, is often complex and requires specific competences. For this reason, Microlab Elettronica offers a complete support in drafting the requested technical documentation, thus greatly simplifying the client’s task, which will only be to take care of more practical aspects, without any concerns about the technical and administrative ones.
The last phase of the process is the mass production of the device. Microlab Elettronica’s distinctive feature is the ability to limit costs also in small series (50/100 products a year) productions. Moreover, Microlab Elettronica takes charge of carrying out the controls and tests at the end of the production as requested by the legislation on the device, before it is delivered to the client for commercialization.