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.
Areas Covered in the Session :
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?
Who Will Benefit:
Research & Development
Quality Engineers and Auditors
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.
Startup Company Leaders