Verifying the Design

Design Verification

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 the design inputs (specifications, regulations, knowledge from previous designs, and any information required for proper function of the…

Evaluating the Design

Design Review

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 Output

Design Output

The next procedure required for the Design process is related to Design Output. Design Outputs are the results of the design efforts, typically coming together as a product specification. During the Design Input process, or immediately following, these Design Output documents need to be prepared: Component and raw material specifications, product/process specifications, drawings, software code,…

Design Input

Design Input

As discussed in the last post, 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…

Control Over the Design Process

Design Control

The next series of “facts” is about Design requirements. The FDA requires all Class II or III medical device manufacturers to prove that they have control over their design process. Design controls provide evidence that there has been a method employed during the product development stage. The intent is to have a system in place…

CFG Authentication

As a follow-up from last week’s post, once you receive your Certificate to Foreign Government (CFG) you may have additional steps to take before a customer can use the document. This entails having the document Authenticated or Apostillized – the difference between the two depends on which country your customer resides in. The Apostille provides…

Shipping Internationally

Certificate to Foreign Government

When a manufacturer of 510(k) registered medical devices ships outside of the U.S., the customer may request a Certificate to Foreign Government (CFG). This is a certificate provided by the FDA, certifying the manufacturer can export their products to foreign countries. By providing the CFG, you are confirming that the medical device is approved for…

ISO

ISO

International Organization for Standards (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…

FDA Form #483

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 to inspect their facility and verify that all processes…

FDA Clearance

Requesting 510(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…