Regulatory issues medical product design

Kucklick, T. R. 2006. The Medical Device R D Handbook. Boca Raton, FL CRC Press. This one-volume handbook is designed for engineers and is focused on product development of mechanical medical devices, from design and prototyping to managing legal and regulatory issues. 

To prepare appropriate protocols, staff must understand research design and statistical inferences for clinical research state-of-the-art research designs and trials therapeutic area guidelines GCP regulatory requirements, guidelines and country-specific issues national and international medical practices sponsor protocol review and approval procedures and possess in-depth investigational product-disease knowledge. 

---