PeakAvenue develops software for engineering, quality, and risk management in the medical technology sector. Our eQMS platform supports companies with MDR-, ISO 13485-, and ISO 14971-compliant processes, end-to-end traceability, and efficient product development.
PeakAvenue – Digital Quality and Compliance for Medical Technology
The development of medical devices places high demands on quality, safety, and regulatory compliance. PeakAvenue supports medical technology companies in efficiently managing their engineering, quality, and risk management processes in a digital environment.
With our integrated eQMS platform, we connect key processes across the entire product lifecycle – from requirements management and risk analysis to FMEA, testing, and CAPA, as well as document management and regulatory documentation.
Our solutions support companies in meeting important regulatory requirements such as the MDR as well as the standards ISO 13485 and ISO 14971. At the same time, they enable end-to-end traceability, transparent processes, and structured collaboration between engineering, quality, and risk management teams.
The PeakAvenue portfolio includes established solutions such as PLATO e1ns, iqs Quality Center, APIS IQ, Osseno ReqSuite, and Isograph Reliability Workbench.
Visit us at MedtecLIVE 2026 and discover how PeakAvenue helps you digitally connect and efficiently manage quality, engineering, and risk management processes in the medical technology sector.