Prevent Product Recalls & FDA Warning Letters with Quality Engineering

Prevent Recalls with Quality Engineering: As regulatory scrutiny on medical devices and security risk management increases, incorporating quality engineering into your software development process is critical. By focusing on a comprehensive testing strategy, robust device safety, risk management processes, and proper documentation practices, you can avoid costly setbacks, such as product recalls or FDA warning letters.

The Value of Early Quality Engineering

Integrating quality engineering at the start of the software development lifecycle ensures you meet all regulatory requirements, reduce risk, and streamline your development process. Here’s how early quality engineering can benefit your project:

• Design for Testability: Develop requirements and acceptance criteria that ensure the software is testable.
• Accurate Documentation: Document the software’s compliance with all requirements.
• Identifying Gaps: Detect and address missing or untestable requirements early.
• Traceability: Maintain full traceability between requirements and testing coverage.
• Risk Mitigation: Identify and manage risks, such as safety and security, through rigorous testing.

MedAcuity’s Expertise in Quality Engineering

With nearly two decades of experience in MedTech software development, MedAcuity offers specialized expertise in software planning, risk analysis, requirements tracing, design, and verification/validation. Our focus on quality engineering helps you reduce the risk of regulatory issues and ensure the timely release of safe, secure, and compliant medical devices.

To learn more about MedAcuity’s services, click here.

We could not have finished our three software releases without MedAcuity quality engineering support. They led by example and improved not just our product but our processes.

Director of Software Development, Life Sciences technology company