Industrial Metrology for Medical Products and Devices

ZEISS successfully and reliably faces these challenges. Being a leading manufacturer of medical technology as well as of measurement and inspection technology, the company ZEISS has a high level of know-how in the industrial production of medical devices and products.

This book presents the metrological solutions for the medical technology and explains their application. The required measuring machines and the task-based sensors are addressed to the same extent as the challenges regarding automated 100 % checks. Methods for checking the reliability of measuring results and evaluating the inspection process quality are presented and the required procedures are described in detail.

The extended regulations for medical devices and products, e.g. by FDA and MDR, place high demands on the measurement technology used and on the electronic documentation of measurement results. This is addressed in detail at the end of the book; in the appendix, easy-to-use checklists for the regulations according to 21 CFR Part 11 are provided.