Medical Device Design Controls: How to Handle, Monitor and Manage

This 3-hr webinar will help you understand the basics of medical device design controls and how to initiate, handle, monitor, and manage them. You will also learn the purpose and scope of medical device design controls, best design control practices, the similarities and differences between FDA and Notified Body design control requirements, and what is expected when an external auditing body examines your design control procedures and documentation.

Most industry personnel are overwhelmed by national and international quality system laws, directives, regulations, standards, and guidance documents. As such, they believe if they obtain quality system certification from a European Notified Body that they will automatically pass an FDA audit. However, this is not the case, especially in the area of design controls. FDA warning letter after Warning Letter prove otherwise True that Europe's quality management system standard (ISO 13485) and U.S.A's quality system regulation (21 CFR Part 820) are very similar in nature; however, your design control system is viewed totally different by the FDA than by the European Union. Not only is it required under law to have design control procedures and records, however the FDA requires you to also have a sound design control system with linkages to other QSR subsystems; whereas the Notified Bodies do not. If top management do not initiate an effective design controls system, not only may regulatory compliance sanctions against the company occur, but the company may also loose its competitive advantage, have customer lawsuits, perform unnecessary recalls, and be known as a company with non-quality products and services.

This webinar will provide valuable assistance to all medical device companies in developing a sound design control system, and initiating, handling, monitoring managing, and maintaining design controls. The focus will be a basic understanding of quality system design controls without confusing everyone with regulatory compliance jargon. The webinar will include the following:

• The definition, purpose and scope of design controls;
• How design controls fit into a quality system;
• Design control basics;
• Human Factors;
• Hazard and Risk Analyses/Management;
• Change Management;
• Validation and Verification Activities;
• 21 CFR Part 820, Design Controls;
• ISO 13485 Design Controls;
• The similarities and differences between FDA and Notified Body Design Controls; and
• The Design Controls subsystem under FDA’s Quality System Inspection Technique (QSIT)

This topic applies to personnel / companies in the medical device industry. The employees who will benefit most include:

• Senior management,
• Regulatory Affairs, Regulatory Compliance, and Quality Assurance personnel, and
• Quality, Manufacturing, and Design engineers.