Design Input Part 5

Design Validation frequently gets confused with Design Verification – they are quite different processes, though.  With verification, you’re making sure that the product meets the requirements identified by customers and regulations.  Validation is where you actually build a functioning version of the product to make sure it performs as expected. In Section 820.3(z), the FDA…

Design Input Part 4

Design Verification is the next required step in the design process.  Verification is literally an examination of evidence to prove the predetermined requirements have been met.  This is an exercise done on paper, where you take all of the design inputs (specifications, regulations, knowledge from previous designs, and any information required for proper function of…

Why Choose Mesa’s PCD?

Mesa’s PCD products are packaged in a controlled environment consistent with ISO 13485. No matter who the BI supplier is, Mesa controls the Deo with our pouches, meaning our PCD provides the most repeatable barrier to RH and EO, this same repeatability cannot be replicated with other packaged medical devices in typical industry EO sterilization…

Design Input Part 3

The next requirement for the design process is the Design Review.  This is set up as a milestone(s) during product development, and is used to evaluate the design in relation to the previously identified requirements.  These checks will help to identify issues before committing to further work on the product.  Per the FDAs definition in…

Design Input Part 2

The next requirement for the design process is the Design Review.  This is set up as a milestone(s) during product development, and is used to evaluate the design in relation to the previously identified requirements.  These checks will help to identify issues before committing to further work on the product.  Per the FDAs definition in…

Need Help Finding the Right PCD?

To help streamline your Process Challenge Device (PCD) selection process, Mesa Labs has created a PCD Selection Guide. Please utilize this document as a reference when choosing which PCD is best for you. The guide provides valuable information such as important safety info, the Deo Min, the BI Manufacturer and Reorder Number for a variety…

Design Input

As discussed last week, there is specific documentation that needs to be in place for the design process.  This week we will cover the topic of design input, and in following weeks we will address the other required design procedures. Design and development activities can be performed to create new products or to update devices…

What is the ISO?

International Organization for Standardization (ISO) was created so that companies would have a consistent way to ensure products and services were created to be safe, reliable and of a good quality.  These standards provide a way to help organizations continuously meet and exceed their customers’ needs.  They also provide a stepping stone to meeting regulatory…