This seminar is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company’s face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant. 

This course will ensure that Device companies will know exactly what documentation needs to be prepared. They will also know how to ensure the documentation is prepared correctly so the software portion of the submittal will be in compliance preventing delays of the 510K approval. 

However, you will soon be overwhelmed by continuing to apply paper document methods and approaches to software configuration and validation. Rather than wait to be surprised by unexpected situations, or to implement requirements haphazardly, it is better to understand what the hands-on challenges of dynamic requirements as they push the boundaries of technology and new applications.

This seminar is also an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.

Why Should You Attend:

Developing software for medical devices can be a challenge especially if the device is complicated. You do not know if it is safe enough. You do not know if it tested enough. You do not know if the FDA will consider it for suitability for a 510K. Should your software cause harm to someone you don't know if you are protected from liability should your software fail.

Compliance with IEC62304 is key to ensure your software has been developed to the highest level of safety. Developing software based on the standard shows one way to indicate an intent to ensure the safety of your product. Gives you a framework to ensure you are developing and testing to consistent and stringent standard. Demonstrating compliance with the standard will be apparent in your submission and will be one way to ensure acceptance by the FDA.

Course Outline:

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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

• 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