This exclusive Pack of webinars contain 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


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TOPIC 1

IEC 62304 for Medical Device Software

TOPIC 2

Drafting a Software V&V Documentation Package and Protocol

Speaker: Nancy Knettell
Duration: 60 Minutes
Speaker: John E. Lincoln
Duration: 90 Minutes

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
Agenda:
  • 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

TOPIC 4

IEC 62304 and Demystifying Software Validation using the Principles of LDLC

Speaker: Thomas Bento
Duration: 60 Minutes
Speaker: José Mora
Duration: 180 Minutes

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.

TOPIC 5

Medical Device Cybersecurity and FDA Compliance

Speaker: Carolyn Troiano
Duration: 210 Minutes

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




Agenda:

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

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