ISO 13485 certified engineering company. We help start-ups and SMEs take medical devices, aesthetic equipment and laboratory instrumentation from concept to market — designing products oriented to obtain MDR / FDA clearance.
Medtech hardware & firmware design
Companies that need a technical partner capable of delivering regulated or technically demanding products — without splitting the project across five suppliers.
We work with start-ups and SMEs developing regulated devices: patient monitoring, cardiology, imaging, rehabilitation or digital health. We design products oriented to obtain MDR / FDA clearance — without replacing the client's regulatory bodies. We've done it before with our own products (ECG-Expert) and with client products.
We design the electronics and software of IPL, laser, radiofrequency, HIFU and cryolipolysis equipment. We focus on modern touch interfaces, management apps and cloud integration — real differentiation in the professional channel. These devices fall under MDR Annex XVI, a regulation we've already applied in previous projects.
We modernise analytical equipment, IVD instrumentation and research devices: high-precision electronics, embedded firmware, LIMS integration and component obsolescence management. These devices are regulated under IVDR (the sister regulation to MDR) — a certification cycle we've already completed in previous projects.
We're an engineering supplier. The client retains ownership of the product and the role of legal manufacturer. These are the clear limits of our responsibility.
Activities included in our typical scope
Activities that remain the client's responsibility
What sets us apart from a generic consultancy and from a freelancer: a complete team with experience in regulated sectors.
Hardware, firmware, software and manufacturing under a single interlocutor. No need to coordinate four suppliers to reach the final product.
We hold a current, audited ISO 13485 certification for quality management systems of medical devices. Our documentation fits the client's without adding regulatory friction.
Designing electronics and firmware for demanding sectors since 2002. We know the real cost of a deviation or a late prototype iteration.
Hardware, firmware, application software, mechanical and industrialisation engineers — all in-house. No critical core depends on a subcontractor.
The whole cycle, from idea to the first production batches, runs through our workshop at the Sant Pau Modernist Site. Visits and audits are welcome.
We're part of the CS&E group, which has brought to market its own products distributed in more than ten countries. We don't theorise medtech: we practise it.
A methodology we've refined over 20 years of projects — adaptable to the stage where the client finds us.
We work with the client to set specifications, applicable regulatory requirements, realistic budget and timeline.
Hardware, firmware and software design. We generate the technical documentation (gerbers, BOMs, source code, manuals) following ISO 13485.
Manufacturing of the first prototypes, commissioning, functional verification and support for the clinical or market validation process.
Serial manufacturing, quality control, traceability and after-sales service. Obsolescence management and life-cycle reviews.
We are an ISO 13485 certified company with real track record across the three regulations that govern our sectors:
The same methodology applies to products oriented to FDA. Working with a team that has already lived through the full certification cycle with a Notified Body is the best guarantee that your product will reach the market with its technical documentation ready.
A group device already on the market with MDR clearance and a European project under way with reference partners. We speak with facts, not promises.
Wireless 12-lead electrocardiograph developed entirely by the group's engineering team: isolated acquisition hardware, embedded firmware, native multi-platform apps and serial manufacturing. Developed in collaboration with Hospital Clínic de Barcelona and commercialised by MedicalCSE.
The CS&E group — together with two Dutch partners, Cordys Analytics and UMC Utrecht — is developing an AI platform for stress-ECG analysis, aimed at the early detection of cardiovascular diseases that today go unnoticed on a resting ECG.
The CS&E group's contribution to the consortium: design of the multi-lead electronics, integration with our own device (ECG-Expert) and regulatory experience in MDR Class IIa.
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Tell us about the idea and we'll let you know if it fits our team. No commitment, no hidden quote.
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