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.
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
Development
Risk and consequences
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
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
Development
Risk and consequences
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Jose Ignacio Mora
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of …
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