Design Verification, Validation and Testing for Medical Devices

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.

• 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

Meena Chettiar completed her education in India, Canada, and the United States where she completed master’s degrees in applied chemistry, Chemical Engineering, and Regulatory Affairs for Medical devices respectively. Meena has worked for Health Canada and Agriculture Canada as a Scientist and Quality Control Chemist. After immigrating to the United States Meena worked for Land O’Lakes and key Pharmaceutical and Medical device Companies such as Cephalon, Baxter, and Covidien in Minnesota, USA. Meena recently transitioned from serving as a Quality Director for Welly Health to the Head of Quality at a Cosmetic Company in the DC area.

Meena currently also serves as an Adjunct Instructor for the Medical Technology Program at St. Cloud State University. Meena is a passionate Quality content creator and presenter of webinars in Compliance and Quality. She is the author of Indiana Quality Council’s Biomedical Auditor Primer and is currently working on a Book for the American Society of Quality (ASQ). Meena has acquired several certifications from ASQ such as Quality Auditor, Quality Manager and Organizational Excellence, Quality Improvement Associate and Biomedical/Medical Device Auditor. Meena Chettiar is a continuous learner.