For companies submitting software-enabled medical devices or Software as a Medical Device (SaMD) to the FDA, inadequate software documentation is one of the biggest risks: a 510(k) can be rejected after seven months or more of waiting. Companies without an IEC 62304-compliant software quality system also face audit findings that can block sales.
This 60-minute IEC 62304 training explains what the standard is, how it differs from standards such as ISO 13485, and what makes a system compliant. You'll learn the components of the software lifecycle, the major software work products, and how the standard fits your existing quality process.
The session also covers the legal and audit consequences of not following the guidance.
WHY SHOULD YOU ATTEND?
Developing medical device software raises hard questions: is it safe enough, tested enough, and suitable for a 510(k)? Following IEC 62304 gives you a consistent framework for development and testing, shows intent to ensure safety and makes compliance visible in your submission.
This session suits regulatory, quality, compliance, design assurance and software engineering managers, directors and engineers working on medical device software.
AREA COVERED
The standard
- What IEC 62304 is and how it differs from standards such as ISO 13485
- The regulatory need for IEC 62304 when submitting a 510(k) for software-enabled devices
- The areas the guidance addresses
- What constitutes compliance with the standard
- Elements of an IEC 62304-compliant system
- Benefits of developing to IEC 62304
Development
- Components of the software lifecycle
- Major software work products developed to the standard
- How the standard fits a company's quality process
Risk and consequences
- Why a compliant software quality system matters before and after 510(k) approval
- Not following the guidance as a common reason a software-enabled device is denied a 510(k)
- Legal consequences of not adhering to the guidance
- Audit consequences of not having a compliant quality system
LEARNING OBJECTIVES
- Explain what IEC 62304 is and how it differs from ISO 13485
- Identify the elements of an IEC 62304-compliant software quality system
- Describe the software lifecycle and the major work products
- Integrate IEC 62304 into your company's quality process
- Prepare software documentation for a 510(k) submission
- Recognize the legal and audit risks of non-compliance
WHO WILL BENEFIT?
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Regulatory
- Quality
- Vice President of Compliance and Regulatory
- Compliance Expert
- Software Engineer
- Software Engineering Manager
- Software Compliance Engineer
- Medical Device Software Engineer
- Quality Assurance
- Design Assurance
- Design Engineers
Developing medical device software raises hard questions: is it safe enough, tested enough, and suitable for a 510(k)? Following IEC 62304 gives you a consistent framework for development and testing, shows intent to ensure safety and makes compliance visible in your submission.
This session suits regulatory, quality, compliance, design assurance and software engineering managers, directors and engineers working on medical device software.
The standard
- What IEC 62304 is and how it differs from standards such as ISO 13485
- The regulatory need for IEC 62304 when submitting a 510(k) for software-enabled devices
- The areas the guidance addresses
- What constitutes compliance with the standard
- Elements of an IEC 62304-compliant system
- Benefits of developing to IEC 62304
Development
- Components of the software lifecycle
- Major software work products developed to the standard
- How the standard fits a company's quality process
Risk and consequences
- Why a compliant software quality system matters before and after 510(k) approval
- Not following the guidance as a common reason a software-enabled device is denied a 510(k)
- Legal consequences of not adhering to the guidance
- Audit consequences of not having a compliant quality system
- Explain what IEC 62304 is and how it differs from ISO 13485
- Identify the elements of an IEC 62304-compliant software quality system
- Describe the software lifecycle and the major work products
- Integrate IEC 62304 into your company's quality process
- Prepare software documentation for a 510(k) submission
- Recognize the legal and audit risks of non-compliance
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Regulatory
- Quality
- Vice President of Compliance and Regulatory
- Compliance Expert
- Software Engineer
- Software Engineering Manager
- Software Compliance Engineer
- Medical Device Software Engineer
- Quality Assurance
- Design Assurance
- Design Engineers