Standards and Standardization - How knowledge can protect your ideas and innovations
Standards play an important role for users, research institutes and medical device manufacturers in protecting their innovation activities. They have to know state-of-the-art standards as well as future standards being developed. This is especially important for meeting the criteria of the European Directives and the FDA regulations, for ensuring usability/interoperability, and for using scale effects for production
The EU Commission mandates the European Standards Committee, CEN/CENELEC, to develop standards for proving the compliance of products/systems with the essential requirements of the Directives. If these requirements are met, the Commission publishes a reference to the standard in the Official Journal of the European Community, giving the standard the status of a harmonized standard. It is presumed that manufacturers who observe the harmonized standards will ensure that their products are in compliance as well. Since harmonized standards are still voluntary, whenever manufacturers do not apply them, they must document the alternative solutions adopted to meet the essential requirements of the European Directives.
Participants will learn about the essential requirements of the directives and the judicial importance of standards as a measure for proper technical actions. The course will describe the most important standards (product and horizontal standards) for the development and approval of medical devices, as well as the standardization bodies that prepare them. Knowing how to interpret standards and whom to ask questions about them is useful for all those working in the medical device and instrumentation field. |