Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485: 2016 have specific product verification and validation requirements that must be fulfilled in the medical device industry. FDA is getting more and more stringent about product design requirements for risk management and to fulfill its mandate for safety and efficacy of all medical devices.
The design controls are now being expected from outside equipment manufacturers (OEM) and all suppliers to the medical device industry. This webinar will educate you on the key areas that you need to focus on to fulfill the design control and testing requirements for your medical device at various phases of your product development.
AREA COVERED
- Product development process overview
- Applicable design verification and validation requirements
- Testing requirements including the pertinent ISO Standards
- Translation of user requirements into design inputs
- 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 all stages
- Design outputs and documentation in DMR (Device Master Records) and DHR (Device History Records)
- Proof for how design outputs meet functional and operational requirements
- Compatibility of the design with components and other accessories
- Test requirements to fulfill acceptance criteria for final products
- How to withstand regulatory scrutiny
- How are changes and their effects controlled and documented during the device life cycle?
- Summary
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
- Product development process overview
- Applicable design verification and validation requirements
- Testing requirements including the pertinent ISO Standards
- Translation of user requirements into design inputs
- 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 all stages
- Design outputs and documentation in DMR (Device Master Records) and DHR (Device History Records)
- Proof for how design outputs meet functional and operational requirements
- Compatibility of the design with components and other accessories
- Test requirements to fulfill acceptance criteria for final products
- How to withstand regulatory scrutiny
- How are changes and their effects controlled and documented during the device life cycle?
- Summary
- 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