Since 2002 we've been designing electronics, firmware and software for companies that need a technical partner capable of delivering regulated or technically demanding products. We're not a consultancy: we're the team that manufactures what we design.
Headquarters · Barcelona
TecnoCSE was founded in 2002 as Custom Software & Electronics, S.L. with a clear goal: to offer electronic engineering and software for sectors where errors aren't an option. Twenty-four years later we hold the same principle — and we've added ISO 13485 certification and a track record of own products with MDR clearance on the market.
Our group operates with two complementary brands that cover the full medical product cycle.
Product engineering. We're the team that designs, prototypes and manufactures electronics for third parties. We work with start-ups, SMEs and established companies in medtech, aesthetic medicine and laboratory sectors. The client retains ownership of the product and the role of legal manufacturer.
The group's own product. Commercialises the ECG-Expert device, a wireless 12-lead electrocardiograph developed entirely by our engineering team. Holds CE MDR Class IIa marking (Notified Body 0318) and is authorised for sale in more than ten countries.
See medicalcse.comTecnoCSE is an ISO 13485 certified company — the international standard for quality management systems for the design and manufacture of medical devices. This certification translates into traceable technical documentation, change control, critical supplier management and software life cycle under IEC 62304. Our documentation fits with the client's without adding regulatory friction — and from there we can design products oriented to obtain MDR or FDA clearance, as we've already done with our own ECG-Expert.
Every design, every change and every batch is recorded. If you need to reconstruct the product history for an audit tomorrow, you'll have it.
We develop firmware and software under IEC 62304: planning, requirements, architecture, coding, verification and maintenance.
We work regularly with Notified Bodies and client auditors. Visits to our facilities are welcome.
Our offices and workshop are located at the Sant Pau Hospital Modernist Site, declared a UNESCO World Heritage Site. The whole cycle — design, prototyping, validation and serial manufacturing — runs through here. Technical visits and audits welcome by prior appointment.
Tell us about the idea, the stage you're at and the main challenges. We'll let you know if it fits our team, no commitment.
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