Medical Devices

IEC 62304 and IEC 60601 compliant hardware and software for Class II and III devices

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MEDICAL DEVICES

Medical electronics carry the highest possible stakes: a fault can directly harm a patient. Lorentis designs imaging system ASICs, patient monitoring FPGAs, therapeutic device controllers and implantable device firmware to IEC 62304, IEC 60601 and ISO 14971 risk management standards. We produce the design history files, traceability matrices and verification evidence that regulatory submissions require, and we work alongside your quality and regulatory teams from day one.

CAPABILITIES

IMAGING SYSTEM ASICS

Ultrasound front-end, CT detector, MRI gradient control, X-ray readout

PATIENT MONITORING

ECG, SpO2, NIBP, temperature acquisition FPGAs and SoCs

THERAPEUTIC DEVICES

Infusion pump controllers, ventilator drive electronics, RF ablation

IMPLANTABLE & WEARABLE

Ultra-low-power ASICs, secure wireless, hermetic packaging design

CYBERSECURITY & DATA INTEGRITY

HIPAA-aware firmware, encrypted storage, secure OTA update

REGULATORY SUPPORT

IEC 62304 · IEC 60601 · ISO 14971 · FDA 510(k) evidence packages

Discuss a medical device project →
  • Standards:

    IEC 62304 · IEC 60601 · ISO 14971 · FDA 510(k)

  • Device classes:

    Class I · Class II · Class III

  • Deliverables:

    DHF · traceability matrix · V&V evidence

  • Contact:

    Discuss a medical project →