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.
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.
LEARNING OBJECTIVES
- 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
- 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
WHO WILL BENEFIT?
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Regulatory
- Quality
- Vice President of Compliance and Regulatory
- Compliance Expert
- Software Engineer
- Software Engineering Manager
- Software Compliance Engineer
- Medical Device Software Engineer
- Quality Assurance
- Design Assurance
- Design Engineers
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.
- 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
- 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
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Regulatory
- Quality
- Vice President of Compliance and Regulatory
- Compliance Expert
- Software Engineer
- Software Engineering Manager
- Software Compliance Engineer
- Medical Device Software Engineer
- Quality Assurance
- Design Assurance
- Design Engineers
Speaker Profile
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 …
Upcoming Webinars
Managing Difficult Employee Conversations
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Dealing With Difficult People In Life & Work
Predictive Accounting: Driver-Based Budgeting And Rolling F…
Pay Equity Changes for 2024! What Employers Need to Know to…
Leader Branding: How to Communicate with Confidence to Attr…
Project Management for Non-Project Managers - How to commun…
Design Verification, Validation and Testing for Medical Dev…
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Why EBITDA Doesn't Spell Cash Flow and What Does
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Employee or Independent Contractor – U.S DOL Announces 2024…
How to Survive an Emotionally Toxic Workplace
Best Practices in Complaint Management for Regulatory Compl…
Human Factors Usability Studies Following ISO 62366 and FDA…
Ensuring Safe and Effective Pharmaceutical Products: A Comp…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
Embracing Diversity and Inclusion in Talent Acquisition
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Understanding and Analyzing Financial Statements
Divorce, Adoption and Other Special Tax Topics
Design History File (DHF), the Device Master Record (DMR) a…
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Setting up Quality System for FDA Regulated Products: Tips …
Is Your Culture Working For or Against Your Success? If You…
Marketing to Medicare or Medicaid Beneficiaries - What You …
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
Sunshine Act Reporting - Clarification for Clinical Research
Documenting Misconduct that Will Stand Up in Court
Stress, Change And Team Resilience Through Humor: An Intera…
FDA Regulation of Artificial Intelligence/ Machine Learning
Managing Toxic & Other Employees Who have Attitude Issues
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Pharma 4.0: Next Generation Technology Approach to GxP Prod…
Patient Gifts, Discounts and Freebies: What You Can and Can…
Managing Complex Projects - Project Management
All About Civility - Eliminating a Culture of Gossip Rumors…
From Challenges to Compliance: Understanding Dietary Supple…
Improving Employee Engagement & Retention Through Stay Inte…
How To Conduct An Internal Harassment And Bullying Investig…