Entries with Keyword whitepaper

5 Tips to Pass Your FDA or ISO Audit with Con ...

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.

Managing Your BOM: Spreadsheets vs. Product L ...

Manufacturers rely on the item, assembly, documents, and related product record information that is included in a bill of materials (BOM)

What is the Right Part Numbering Scheme for y ...

We explain the pros and cons of non-intelligent part numbering versus intelligent part numbering and offer best practice insights.

Is Product-Centric QMS Right for Your Company ...

Most product quality problems are fixed by changing the product record—the product design and the documentation that describes how to manufacture

The 5 Essential Elements of a CAPA System

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.

Defect Management—4 Steps to Better Product ...

What are the risks of not making defect management as a priority for the company? Read how to address here.

Form-Fit-Function (FFF) Definition and Rules

For anyone that has dealt with production line issues, you can read why it’s important to embrace form-fit-function rules.

Manufacturing BOMs Are Critical to Successful ...

We explain what manufacturing bill of materials (MBOMs) are and explore how they are different than engineering BOMs.