DUBLIN–(BUSINESS WIRE)–The “Medical Device Software and Cybersecurity Courses – 5 Webinar Pack” webinar has been added to ResearchAndMarkets.com’s offering.
This exclusive Pack contains 5 courses:
1. IEC 62304 for Medical Device Software
2. Drafting a Software V&V Documentation Package and Protocol
3. Validation of Non-Product Software
4. IEC 62304 and Demystifying Software Validation using the Principles of LDLC
5. Medical Device Cybersecurity and FDA Compliance
Total Duration: 10 Hours
Medical device software can make or break a device. Badly developed, non-compliant software can compromise a device’s safety and reliability. The goal is that upon completion of this pack of courses, you should understand how to create and maintain safe software for medical devices throughout their life cycles. In addition to this, you should also understand how IEC 62304 interlinks with other standards such as ISO 14971 and ISO 13485.
The courses include IEC 62304 requirements and explains risk-based approach for Verification and Validation using protocols and GAMP. What if your software is not a product; how would you validate it? Well, this pack has answers to that.
Next, it takes you through a process of software validation giving you a complete overview of the imminent changes and their implications, using an innovative approach yet is based upon solid principles and proven practices. And finally, and importantly, the cyber-attacks threaten medical devices and how the industry is currently responding to them. You will learn the many ways of preventing and mitigating the cybersecurity risk, and about the industry’s best practices that can help your company do the same.
Who Should Attend:
- Senior management, Project Leaders, Internal/External consultants
- Mid-level Management and Supervisory Personnel
- Regulatory Affairs Departments
- Quality Systems/QAE Departments
- R&D Departments
- Engineering Departments
- New Product Development Departments
- Validation Technicians
- IT Departments
- Medical Device, Equipment/Process SW Programmers
Agenda
TOPIC 1: IEC 62304 for Medical Device Software
Speaker: Nancy Knettell
Duration: 60 Minutes
- 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
- 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
TOPIC 2: Drafting a Software V&V Documentation Package and Protocol
Speaker: John E. Lincoln
Duration: 90 Minutes
- Verification or Validation
- Current Regulatory Expectations and “Hot Buttons”
- The Project Validation Plan
- Product and Process / Equipment Software V&V
- When and How to Use DQ, IQ, OQ, PQ
- GAMP Considerations
- The FDA’s 11 Key Elements
- White Box and “Black Box” Validations
TOPIC 3: Validation of Non-Product Software
Speaker: Thomas Bento
Duration: 60 Minutes
- Software used as part of the manufacturing process (including software embedded in machine tools, statistical process control software, programmable logic controllers [PLCs], and software in automated inspection or test systems).
- Software used in process validation (such as statistical calculation software, spreadsheets, etc.).
- Software used in design and development processes (such as CAD software, CAM software, software development tools, software test tools, compilers, editors, code generators, etc.).
- Software used to automate part of the quality process (such as complaint-handling systems, lot-tracking systems, training-database systems, etc.).
- Software used to create, transmit, modify, or store electronic records that are required by regulation.
- Software used to implement electronic signatures for documents required by regulation.
TOPIC 4: IEC 62304 and Demystifying Software Validation using the Principles of LDLC
Speaker: Jose Mora
Duration: 180 Minutes
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
TOPIC 5: Medical Device Cybersecurity and FDA Compliance
Speaker: Carolyn Troiano
Duration: 210 Minutes
Session 1:
- Cybersecurity and guidance on device software
Session 2:
- Most common problems faced by the industry in terms of medical device security, efficacy, and safety
Session 3:
- Best practices and industry standards to meet the challenges of cybersecurity and other threats to devices and software
For more information about this webinar visit https://www.researchandmarkets.com/r/n9c22s
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