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 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 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 requirements for your medical device.
Areas Covered in the Session :
- Product development process overview
- Applicable design verification and validation requirements
- Testing requirements including the pertinent ISO guidelines
- Translation of user requirements into design inputs and role of testing and regulatory requirements
- Fulfilling critical to customer and critical to 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)
- Test requirements to fulfil 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
