Under FDA regulations device labelers must generate a unique device identifier (UDI) for each of their products that are headed to market. This identifier will then be stored within the global unique identification database (GUDID) allowing for eased product lookup. However, certain class I and unclassified devices are not required to be a part of the GUDID. The UDI allows for eased tracking of devices that are in distribution from either human or machine-readable identifiers.
All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality
Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system. 21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”. The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action
In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.
All of life entails some about of risk. The most humans can really do is mitigate the destructive effects of these risks that we take on a daily basis., the same goes with medical devices.
The Significance of Design Controls
In the 1980s, the Food & Drug Administration (FDA) studied the causes of voluntary recalls of medical devices. Between October 1983 and September 1989, they found that about forty-four percent of these recalls were due to design issues.
Paperwork: The Necessary Evil
No one genuinely enjoys doing paperwork. At best, people may dislike paperwork less than other parts of their jobs. Yet the FDA requires a certain amount of paperwork to document processes and results for the medical devices under their jurisdiction
Product Failures and Root Cause Analysis
In one’s personal life, many people just shrug their shoulders, and go about their day; however if a multi-million dollar investment, or someone’s life, is on the line, engineers need to take steps to prevent it from happening again.
Introduction to the Seven Basic Tools of Quality
Ishikawa collected the seven most powerful methods for solving problems in manufacturing quality….
Making Quality Systems Work for You
If your QMS does not have the proper elements, personnel are not appropriately trained, or your firm does not really value the advantages of your QMS, you will likely not reap the same reward.
No Quality System Required: Quality Management for Unregulated Industries
By the time I began work as a Quality Engineer for The Gillette Company, in the early 1980’s, I had worked for several other organizations. None of them had Quality Management Systems, or a ‘QMS’
Customer Needs vs Requirements
Understanding customer needs and their requirements is critical for an organization to stay in business and are often used interchangeably. Yet, they are not the same.