Customer Introduction

This medical technology startup has developed a disposable wearable wristband that collects motion data and assesses the activity levels of its users over time. Once worn and returned, clinicians analyze the collected data and compile it into an activity report. The company partnered with Voler Systems to create software that meets the requirements for 510(k) approval and facilitates a smooth transition to volume production.

Problem/Goal

• No production-ready data extraction or reporting solution
  
  Develop a software application for extracting data from the device and generating reports.
• Regulatory compliance gaps in the software development process
  
  Ensure compliance with IEC 62304 to meet FDA submission requirements.

Solution

Voler Systems provided tailored engineering solutions to complete the client's product development and ensure regulatory readiness:

• Developed a PC-based application to extract data from the wristband.

• Generated a clinician-friendly activity report.

• Guided the client through a compliant software development process to meet FDA regulatory standards.

Results & Benefits

• Delivered a production-grade data extraction and reporting system that simplified the process of managing, collecting, and analyzing device data for doctors to review patient activity data.

• Developed software that is fully compliant with IEC 62304, reducing the risk of regulatory issues and facilitating a smoother FDA submission process.

Inspiration

Voler Systems takes pride in helping innovative startups navigate regulatory challenges while focusing on product development. By offering expert engineering support, Voler ensured the client could confidently proceed with FDA submission and production.

Contact Voler Systems today to learn how our engineering solutions can help elevate your product and meet regulatory requirements efficiently.