3-Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

If your company need to file for 510K approval for Software as a Medical Device (SaMD) or software enabled medical Devices to the FDA for, this webinar is for you. After waiting for seven or more months to find you’re device approval has been denied because the software section of the submittal is inadequate and not compliant is one of the biggest challenges device companies face today. Medical device companies need to join this webinar to ensure that they know exactly what documentation needs to be prepared and submitted. They will also understand how to warrant that all documentation is prepared appropriately so the software portion of the submittal compliant to IEC 62304 regulations. This will ensure delays of the 510K approval are prevented. This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software Life-cycle and software validation protocols. Rather than be overwhelmed by continuing to apply paper document methods and approaches to software configuration and validation, it is better to understand what are the practical challenges to the dynamic requirements as devises keep pushing the boundaries of technology and new applications. This will ensure you are not caught off guard by unexpected situations and do not implement requirements haphazardly. Get a complete overview of the imminent changes and their implications, using an innovative approach yet is based upon solid principles and proven practices.

Seminar Agenda:

Lecture 1:

• Why is having an IEC62304 Compliant Software Quality System important to both developing your software for 510K approval and how you can be putting your company at risk post-approval if you do not have a compliant system in place
• What is IEC62304 and how does it differ from other Compliance Standards such as ISO13485
• What are the elements that constitute an IEC62304 Compliant System?
• Benefits of developing to an IEC62304 standard
• What are the components of the Software Lifecycle
• What are the major Software Work Products developed to the standard?
• How it fits in with a Company’s Standard Quality Process
• What are the legal consequences for the company with the submittal if the company does not adhere to the Guidance

Lecture 2:

• One of the most common reasons that a Software Enabled Medical Device is denied a 510K is because the Guidance has not been followed
• What are the potential audit consequences if the Company does not have an IEC62304 Compliance Quality System in place
• Understand the regulatory need for IEC 62304 Guidance as it relates to submitting a 510K for Software Enabled Medical Devices
• What constitutes compliance with the Standard
• What areas does the Guidance Address
• What are the legal consequences for the company with the submittal if the company does not adhere to the Guidance

Lecture 3:

• Review of Lean Documents and Lean Configuration concepts
• Software Validation:
  • Software configuration
  • General setup
  • Organization
  • User Management
  • Rights Groups, Roles, and Actors
  • Products
  • Processes
  • Failure Modes, Process Signals, Tasks
  • Screens, menus, and modules
  • Process validation steps
• Bringing them all together

Who Should Attend:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Research and Development Departments
• Compliance Departments
• Production Departments
• Documentation Departments
• Operations Departments
• Medical Device Software Engineers
• Medical Device Software Validation Departments
• Medical Device Software Compliance Engineers
• Document Control Teams

Course Director: JOSÉ MORA

José 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. José 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, José 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 José’’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.