Design control is central to any quality system in a regulated industry. FDA's Quality System regulation and inspection technique (QSR and QSIT) and ISO 13485:2016 both set specific design verification and validation requirements for medical devices, and FDA is becoming stricter about design requirements for risk management, safety and efficacy.

This 60-minute medical device design verification and validation webinar covers what to focus on at each phase of product development. You'll see how user requirements become design inputs, how verification and validation cycles run, and how traceability and risk management carry through every stage.

The session also covers documenting design outputs in the DMR and DHR, testing to acceptance criteria and controlling changes across the device life cycle.

WHY SHOULD YOU ATTEND?

FDA now expects design controls not only from device makers but also from outside equipment manufacturers (OEMs) and all suppliers to the medical device industry. This session shows how to meet design control and testing requirements and withstand regulatory scrutiny.

It suits senior and middle management, R&D, quality and manufacturing engineers, regulatory affairs, QA and QC staff, device design, development and manufacturing teams, those who plan and run verification and validation, and start-up leaders.

AREA COVERED

• Overview of the product development process
• Applicable design verification and validation requirements
• Testing requirements, including the relevant ISO standards
• Translating user requirements into design inputs
• The role of testing and regulatory requirements
• Focusing on critical-to-customer and quality requirements
• Design verification and design validation activity cycles
• Traceability and risk management at every stage
• Design outputs and documentation in the device master record (DMR) and device history record (DHR)
• Showing how design outputs meet functional and operational requirements
• Compatibility of the design with components and accessories
• Test requirements to meet acceptance criteria for final products
• Withstanding regulatory scrutiny
• Controlling and documenting changes and their effects during the device life cycle
• Summary

LEARNING OBJECTIVES

• Explain FDA QSR and ISO 13485 design verification and validation requirements
• Translate user requirements into design inputs
• Plan design verification and validation cycles with traceability and risk management
• Document design outputs in the DMR and DHR
• Set test requirements that meet final product acceptance criteria
• Control and document design changes across the device life cycle

WHO WILL BENEFIT?

• Senior management
• Middle management
• Research & Development
• Quality Engineers
• Manufacturing Engineers
• Regulatory Affairs Professionals
• Quality Assurance & Quality Control Personnel
• Device Design Team
• Device Development Team
• Device Manufacturing Team
• Verification and/or Validation planning, execution and documentation for devices.
• Start up Company Leaders