AchievedINNVAL 23/18
Research project at IFCA
Silicon carbide diodes validated as suitable for HDR brachytherapy, with measurements on a real ¹⁹²Ir source at HUMV and a favourable ethics committee opinion.
Roadmap
From prototype to CE marking
Our device is expected to be a Class IIb medical device under the EU Medical Device Regulation (MDR). This is the path we have planned to reach the market, milestone by milestone.
ProductClinicalRegulatory & qualityIntellectual propertyAchieved
2023–25
Achieved2025
UCem entrepreneurship award
University of Cantabria award for the business project.
2026
Achieved2026
Company founded and first flexible boards
Particle Care Technologies S.L. is incorporated at CDTUC. Independent patentability report and selection for TOP101 Spain Up Nation.
We are here
2026
ProductQ4 2026 – Q2 2027In progress
P1Probe consolidation
A sealed, stable probe that gives repeatable measurements.
Regulatory & qualityQ4 2026 – Q1 2027
R1MDR classification and regulatory roadmap
Formal classification report, checked with a notified body.
MDR Art. 51 · Annex VIII2027
ProductQ1 2027 – Q2 2028
P2Readout electronics and complete demonstrator
Developed with Tekniker and refined through a measurement campaign at HUMV.
Regulatory & qualityQ1 – Q4 2027
R2Quality and risk management
Quality management system and risk management file.
ISO 13485 · ISO 14971Intellectual propertyQ2 2027
European patent application
Priority filing with the European Patent Office.
ClinicalQ3 2027 – Q1 2028
C1Validation at Hospital Virtual Valdecilla
On an anthropomorphic phantom we reproduce a correct and an incorrect treatment, and check that the system tells them apart, with no risk to patients.
2028
Intellectual propertyQ2 2028
International PCT application
Within 12 months of the priority date.
ClinicalQ2 2028 – Q2 2029
C2Patient study at HUMV
Measured dose compared with planned dose in real treatments, and impact on the patient workflow. The basis of the clinical evaluation report.
ProductQ3 2028 – Q2 2029
P3Design freeze
Embedded software and usability verified.
IEC 62304 · IEC 62366-12029
ProductQ3 2029 – Q1 2030
P4Electrical safety and EMC testing
Tests in an accredited laboratory.
IEC 60601-1 · IEC 60601-1-2Intellectual propertyQ4 2029
National and regional phases
Protection in Europe and the United States.
2030
Regulatory & qualityQ1 – Q2 2030
R3Technical documentation
Complete technical file.
MDR Annexes II–IIIRegulatory & qualityQ3 2030 – Q1 2031
R4Notified body assessment
Audit of the quality system and review of the technical file.
MDR Annex IX2031
Regulatory & qualityQ2 – Q4 2031Final milestone
R5CE marking
CE certificate, EU declaration of conformity, UDI and EUDAMED registration. The device can be sold in the European Union.
MDR Art. 20 · 27 · 292032+
ProductFrom 2032
Digital integration
Integration with treatment planning systems and afterloaders, followed by AI-assisted fast Monte Carlo plan optimisation.
Dates are estimates and may change as the project progresses. Milestone codes: P = product, C = clinical, R = regulatory.