MedLumics

MedLumics is developing an innovative Image-Guided Radio-Frequency ablation catheter system for the treatment of atrial fibrillation. The device is based on optical coherence tomography (OCT), which uses optical waves to generate a high-resolution, cross-sectional view of tissue.

What we delivered:

• Market / Product Requirements Specifications (Design Inputs)

• Risk Management Plan

• Preliminary Usability Evaluation

• Use Specification

• Use FMEA

• Preliminary Hazard Analysis

• Software Requirements Specification

• Software Development SOP

• Preclinical Testing Support

• Intellectual Property development

• Design Verification Strategy

• Design Verification protocols

• Labeling Requirements Specification

• Sterilization Validation Strategy & protocol