Dennis Payton
Tue, 04/08/2014 - 17:00
Two Productivity Tools for Creating Quality Products An enterprise resource planning system and a QMS bring more value when used together
Tue, 04/08/2014 - 17:00
In 1908, the first Model T was created and more than 15 million were sold through mid-1927, proving that a focus on core product can create a tidal wave of success. The plan and processes Henry Ford put in place to create the Model T revolutionized…
Interpreting the FDA View of Medical Device Design Controls What the regulations lack in length they make up in complexity
Mon, 01/20/2014 - 10:44
Some of the shortest descriptions in the Food and Drug Administration's (FDA) CFR 21 Part 820—“Quality System Regulation” are found in Section 820.30 and Section 820.40, totaling about a page of information about design and document controls.…
Why Product Life Cycle Is Critical in Medical Device Design Control FDA auditors look for solid evidence of design control and tracking of all processes
Fri, 09/13/2013 - 16:48
Given the Food and Drug Administration’s (FDA) increased findings for companies that must comply to CFR 21 Part 820—“Quality system,” it’s curious that the oversight body has not offered much guidance about product design control, particularly…
FDA, Industry Grapple with Similar Quality, Technology Challenges FDA is making an effort to keep industry informed of its thinking
Mon, 06/27/2011 - 05:00
With the explosive growth in imported goods to the United States, what is the Food and Drug Administration (FDA) doing toward maintaining a level of service inspection that ensures the best protection of the public health? One option is to partner…