Ironbarque

Medical Device Consulting Regulatory Quality Complaince

Really, We Still Have to Have these Discussions?

The Case For Quality - Just A Comment

The FDA and Industry are working together to attempt to spread the message that the prospective attention to quality systems will pay dividends.

There is a specific FDA website dedicated to the CASE for QUALITY. which contains much good content:

  • MDICs one of the principal industry partners

  • The has been remade by external consultants.

That there is still the need for such collaboration is of concern to the FDA; hence their increasing willingness to prosecute. The case for quality has been being made for over 30 years. Crosby wrote Quality is Free1 back in 1979. His abbreviated summary for Executive Management is worth a quick read, click . The Japanese embraced Demming and others in the 1970's. Even the US Military recognized the case for quality back in 1992 quoting Deming, Crosby and Juran, click .

So, the real question is: "How do you champion quality system change in your organization?"

Contact us, we can help.

1.Quality is Free. New York: McGraw-Hill. ISBN 0-07-014512-1. (1979).