This seminar will cover the Design Control requirements under FDA and ISO 13485. It will discuss when and how to start the design control process for a new product or significant change to a product. The basics of all areas of design controls from Planning through Product Transfer will be covered. In addition you will be shown an easy way to get a handle on what documentation is required and who the most logical person to create that documentation. You will also learn where and why quality should be involved throughout the product development process.