Design Control for Medical Devices

Trust Is Good, Control Is Better? – Rely on the Creativity of Your Development Team and Use Design Control for Effective Design Management

Two-Day Applied Course

Do you want to develop safe and high-performing medical devices that not only meet regulatory requirements but also respond effectively to market needs?
To achieve this, you need both an excellent development team and a structured process that supports creativity and innovation while keeping it aligned with regulatory expectations.

Design and Development Control (commonly referred to as Design Control) is not only a practical necessity but also a regulatory requirement under ISO 13485 as part of the quality management system. It is a prerequisite for CE marking under the EU Regulations (MDR 2017/745 and IVDR 2017/746) and for product approval in the United States.

But what exactly is Design Control?
As defined by the U.S. FDA, Design Controls are “a set of interrelated practices and procedures that are incorporated into the design and development process – a system of checks and balances.” They ensure that systematic evaluation of design becomes an integral part of product development.

In this interactive seminar, you will deepen your understanding of the medical device development process, learn both European and U.S. requirements, and explore practical tools for efficient design control implementation. Numerous real-world examples and actionable tips will help you translate regulatory expectations into effective practices within your organization.