Design Verification, Validation and Testing for Medical Devices

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.

• 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

• 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

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.

• 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.