This course 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. They also face potential audit risk which might prevent them from selling their approved product if they have been found to not have an IEC62304 Compliant Software Quality System.
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. Companies can also face potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully. This course will ensure that you know what is expected to have in place for compliance for your company during the preparation of a 510K to prevent this risk.
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.
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
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.
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 …
AI for Excel Professionals: Enhancing Productivity with Cha…
Leadership: Strategic Planning and Decision Making
2026 Form I-9 Changes & New ICE Penalties: What Every Emplo…
Human Factors Usability Studies Following ISO 62366 and FDA…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Bootcamp for New Managers and Supervisors: Develop These Es…
FDA Compliance for Regulated Systems using COTS, Cloud, and…
Implementing an Effective Succession Plan to Identify, Deve…
Boost Financial Analysis with Claude in Excel
ChatGPT for HR - Build HR Policy Framework and Strategy
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…
The Anti-Kickback Statute: Enforcement and Recent Updates
Wage & Hour Laws: Ensuring Compliance with the Fair Labor S…
Emotional Intelligence: Mastering the Emotions of Great Lea…
Expense Reimbursements 2026 - Proper Recordkeeping and Acco…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Construction Lending And Real Credit Administration: Evalua…
Dealing With Difficult People: At Work & In Life
Claude AI For CPAs & Finance Professionals: Best Practices …
Secrets Of The Staffing Fix - Solving The Employee Training…
Mastering the Prompt: How Every Professional Can Use AI to …
Eliminate Harmful And Unproductive Drama In The Workplace
Using Copilot to Format Legal Documents in Microsoft Word
Setting SMART Goals & Leveraging Storytelling for Reporting
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
Discover how Emotional Intelligence turns AI from a technic…
Introduction to Microsoft Power BI Dashboards
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Major cGMP Issues: FDA Concerns in 2026
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managers/Supervisors: New Role, Same Team - How to Lead Wit…
HR Auditing - New Update on Important Issues for 2026
2-Hour Virtual Seminar on In-Person Onboarding Your New Hir…
6-Hour Virtual Boot Camp on Microsoft Power BI
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Managing Toxic Employees: Strategies For Leaders To Effecti…
California Meal and Rest Breaks: What You Don't Know Can Co…