What is a 483?

In the medical industry, you will hear that a company has been issued a 483 by the FDA.  While most people are aware that this is a serious thing, many may not understand what, exactly, that means. The FDA has the authority to visit a manufacturer for the purpose of inspecting the facility and verifying…

Requesting a 501(k) Clearance

Prior to a company deciding to request a 510(k) clearance from the FDA, months (if not years) are spent designing a product and conducting tests to prove that this new device will function as expected in the intended application.  When it is decided to finally seek clearance, all of the relevant information is compiled into…

“Immediate Use” vs. “Flash” Steam Sterilization

Traditionally the term “flash” has been used to describe situations where an instrument would be sterilized unwrapped in an abbreviated cycle and used quickly post-sterilization without being stored. This term no longer accurately reflects the current use of steam sterilization for situations where an instrument must be used so soon post-sterilization and the accompanying procedure…

Mesa Labs Acquires Process Challenge Device Business

Lakewood, Colorado, October 15, 2014 – Mesa Laboratories, Inc. (NASDAQ:MLAB) (we, us, our, “Mesa” or the “Company”) today announced the acquisition of substantially all of the assets and certain liabilities of the process challenge device business (the “PCD Business”) from PCD – Process Challenge Devices, LLC, a California company (“PCD-LLC”). The acquisition of the PCD Business is…