Entries with Keyword whitepaper
An FDA or ISO audit is a necessary and potentially difficult part of doing business for any medical device manufacturer. For startup medical device manufacturers the first audit of your processes can be as nerve-racking as the first time you defended your business plan before venture capitalists, submitted your first 510(k) application, or delivered your product to market.
Manufacturers rely on the item, assembly, documents, and related product record information that is included in a bill of materials (BOM)
We explain the pros and cons of non-intelligent part numbering versus intelligent part numbering and offer best practice insights.
Most product quality problems are fixed by changing the product record—the product design and the documentation that describes how to manufacture
Using a compliant quality management system (QMS) with a CAPA subsystem, your company will be ahead of the 465 companies with CAPA-related FDA 483s.
What are the risks of not making defect management as a priority for the company? Read how to address here.
For anyone that has dealt with production line issues, you can read why it’s important to embrace form-fit-function rules.