Medical Device Software Per IEC 62304
Learn what IEC 62304 requires, how a compliant software quality system fits your quality process, and what documentation the software part of a 510(k) submission needs.
Speaker
Jose Ignacio Mora
Medical device quality consultant · Atzari Consulting · 30+ years in medical devices
Overview
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 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.
What’s covered
- 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
- Components of the software lifecycle
- Major software work products developed to the standard
- How the standard fits a company's quality process
- 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
Who should attend
What you get
About the speaker
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 controlled documents and a template for strategic deployment. Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa's business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis' first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, Jose managed the Maintenance and Facilities Department, taking that operation to a level rated as "tops" by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose's leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches
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