Company: Startup developing innovative medical technology

Industry: Medical Devices

Use Cases: Software Documentation Compliance for Regulatory Approval

Services Used: Firmware, Software, Sensors

Results:

• Software documentation fully complies with IEC 62304 for submission
• Customized templates enabled documentation management and compliance
• Enhanced unit testing process

Customer Introduction

This startup company was developing cutting-edge medical technology to improve patient outcomes. They required assistance ensuring their software documentation met stringent regulatory standards, specifically IEC 62304, which governs software development for medical devices. Voler Systems was engaged to support its compliance efforts, providing the tools and expertise needed to meet these crucial requirements.

Problem/Goal

• Current software architecture and design documentation lacked key elements required by IEC 62304 standards.
  Develop a compliant software architecture and design documentation structure that aligns with IEC 62304 standards.
• Documentation gaps existed in unit testing processes, particularly in tracing tests to design elements.
  Define and implement a unit testing strategy that ensures traceability between unit tests and the software design, meeting regulatory standards.
• Existing documentation could lead to extended auditor scrutiny and potentially delay regulatory approval.
  Create clear, auditor-friendly documentation that minimizes questions by establishing a one-to-one mapping with IEC 62304 requirements.
  
  

Solution

Voler Systems was hired because of its rich history in helping medical device startups meet regulatory guidelines. Voler provided the following solutions:

• Conducted gap analysis by thoroughly reviewing the client's documentation and comparing it against IEC 62304 requirements.
• Created customized templates for client software documentation, including architecture, design, and unit testing.
• Assisted client in refining its unit testing strategy to ensure traceability between the unit tests and the software design.

Results & Benefits

• Restructured software documentation fully complies with IEC 62304 standards, ensuring the client is well-prepared for regulatory submission.
• Customized templates and guidance helped the client's internal team gain the tools and knowledge to manage their documentation efficiently, reducing dependency on external consultants and ensuring ongoing compliance.
• Enhanced the unit testing process with a clear strategy for tracing tests to design elements, improving testing strategy, increasing overall quality and reliability of software, and reducing the risk of future regulatory issues.

Inspiration

Voler Systems takes pride in helping innovative startups navigate the complexities of regulatory compliance. By offering tailored solutions and ongoing support, Voler ensures its clients can focus on product development while confidently meeting regulatory standards.

"Voler Systems provided exactly what we needed—a clear path to compliance and the tools to maintain it. Their expertise was invaluable in preparing us for regulatory success."

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