WHO I AM

My name is William Hoover. I have managed R&D "Systems" groups in the Diagnostics industry for 33 years, the last 10 years of that time at the Director level. Most of this work has been technical such as when I created the concept for the Access immunology instrument currently being distributed by Beckman Coulter. Some of the systems I have worked with are illustrated on the "Welcome" page of this site.

In addition to the technical aspects of Systems Engineering and Validation, I have been involved with defining and improving the product development process. This started in 1992 when the FDA released their draft, "Pre-Production Quality Guidance", which eventually became the Quality System Regulations in 1997. Based on the draft guidance, I produced procedures for risk management, hazard analysis, requirements management, design control and documentation. In 1996, when the final guidance document from the FDA was released, called the Quality System Regulations, my processes were used as input to the corporate effort to become compliant.

In 1997 and 1998 at a new corporation, I was again involved in defining compliant product development and design control processes. At every new corporation since that time, I have continuously been refining the processes, making them more compliant and more efficient.

Since 1992 I have also been engaged in selecting or creating software tools used to support both the product development and the design control processes. This has involved both evaluating, selecting and finally configuring the software tools for use. These tools have had a dramatic impact improving the efficiency and reliability of product development. To view my past companies, you may use the hyperlink below to view my profile on LinkedIn.

"Processes, which enable the product development teams to work efficiently and effectively, are my primary goal."

I have interacted with companies ranging from Japan to Australia and accross Europe. The following logos represent some of the companies I have worked with.

The displayed logos are the trademarks of the respective companies. The display does not indicate the support or advocacy for WM Hoover Consulting by these companies. The display also does not indicate a current business relationship between WM Hoover Consulting and the companies.