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 …
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Launch Your Career: The Ultimate Guide for Emerging Profess…
Moving From an Operational Manager to a Strategic Leader
Discover how Emotional Intelligence turns AI from a technic…
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Empowering Conflict Resolution: Letting Go to Gain Control
The 60 Minutes Introduction to DAX
The 6 Most Common Problems in FDA Software Validation and V…
High-Impact Performance Management: Tools, Tactics & Coachi…
AI Across the Business: Practical Use Cases for Founders an…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
The Anti-Kickback Statute: Enforcement and Recent Updates
Do's and Don'ts of Giving Effective Feedback for Performanc…
Emotional Intelligence: Mastering the Emotions of Great Lea…
Copilot and HR: An Introduction for HR Professionals
Goal Mastery: From Resolutions to Results in 2026
Your AI Advantage: How HR Professionals Can Use Claude to S…
Human Error Reduction Techniques for Floor Supervisors
Validation of FDA-Regulated Medical Device and SaMD Product…
Human Factors Usability Studies Following ISO 62366 and FDA…
Managing Toxic & Other Employees Who Have Attitude Issues
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…
Major cGMP Issues: FDA Concerns in 2026
4-Hour Virtual Seminar on Transformational Leadership - The…
Understanding EBITDA – Definition, Formula & Calculation
DOL Reverses Course on Independent Contractor Rule for 2026…
Managing Toxic Employees: Strategies For Leaders To Effecti…
ChatGPT and Project Management: Leveraging AI for Project M…
Navigating HR Like A Pro: What Every Small Business & New H…
HPLC Analytical Method Development and Validation
Negotiating Skills For Professional Results - Winning Strat…
Managing Projects When AI Joins the Team: Human Judgment, A…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Paying and Receiving Payments for Referrals: You Can Go to …
Ten Red Flags that Signal Financial Distress in Business Cu…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Fatal Errors Employers Make When Updating Employee Handbook…
AI Fundamentals for All Leaders and Managers: How to Work S…