Accelerated Testing and Validation

This unique cross-disciplinary guide brings sound business practice and engineering innovation together, to help improve testing techniques in new product development.

Design Controls for the Medical Device Industry

This publication provides real-world examples, strategies and templates for the implementation of effective design control programmes that meet ISO 9000 and FDA QSR standards and regulations.

Compact Regs Part 11: CFR 21 Part 11 Electronic Records;

The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources.