Medical Device Software and Cybersecurity Courses - Pack of 5 Webinars

Agenda:

• 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

• 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

Agenda:

• 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.

Medical Device Cybersecurity and FDA Compliance

Agenda:

• 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

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