Articles Tagged with ''compliance''

Have you ever noticed how many manufacturing companies include the word “quality” in their taglines?

A fundamental shift is taking place in the way companies are approaching regulatory compliance. A lack of structured data is proving to be a substantial liability—as ill-prepared companies are learning the hard way—which is leading more organizations to move away from conventional document-centric methodologies and toward a data-centered model of compliance.

Anyone involved in medical device manufacturing knows that their industry is highly regulated. Almost every medical device manufacturer or pharmaceutical supplier uses materials testing systems in their quality control and research laboratories or outsources their testing to approved third-party laboratories. 

Nondestructive testing (NDT) is used in engineering industries to test equipment, components, and materials without causing any damage. With a reliance on quality assurance and rating systems for tools to be used for the correct tasks, adhering to industrial safety norms is a large factor behind the NDT market.

Which is more important to you: complying with industry and federal regulations, or improving the efficiency and profitability of your operations?

When dealing with medical problems, the medical device should not add to these problems. Medical device manufacturing requires the highest quality—and industry takes no chances with this. Regulations are de rigueur. The need for quality of a bone screw should be obvious, and the same goes for any medical device.

A good day on the shop floor has everything running smoothly. No issues with machines, staff, or suppliers, and products are shipped on time and without defects.

FDA 21 CFR Part 11 compliance is mandatory for medical device and pharmaceutical companies that supply products into the United States.

NASA. Volkswagen. BP. It’s not hard to find examples of quality gone awry. The consequences of the Challenger disaster, VW’s Dieselgate, and the Deepwater Horizon were tragic and far-reaching. While these are some of the most well-known incidents, stories of quality failures are numerous and almost constant.

Hazard- and risk-based approaches to product design and manufacturing may be required by some standards, but they are also simply good practice. These approaches require a more holistic view of the product, intended use, skillset of users, materials, environment, and end-of-life.