How Torque Control Can Help Companies Comply with FDA 21 CFR Part 820 Regulations

Medical device manufacturers who sell their products in the United States must comply with the quality control guidelines outlined by the U.S. Food and Drug Administration in part 820 of Title 21 of the Code of Federal regulations. These guidelines lay out specific requirements for quality systems, covering production and process control, corrective and preventive…

Do You Know How to Improve QMS with Torque Control? If Not, It’s Time to Learn!

Every manufacturing company should have a quality management system (QMS). In many industries, it’s required by law. In every industry, it’s common sense—without a system in place to detect production errors, any little mistake on the line can turn into a big problem once the product leaves your facility. Whether it’s to meet critical safety…

Torque wrench accuracy ranges help you tighten fasteners to the perfect level.

Keep It Tight (But Not Too Tight) by Knowing Your Torque Wrench Accuracy Ranges

In 2017, the International Organization for Standards (ISO) updated its guidelines for the accuracy and calibration of hand torque tools, previously modified in 2003. It was a comprehensive update that split the standard into two parts. The first part, ISO 6789-1:2017, lays out requirements for the design and testing of torque tools to ensure they…

Using the right torque wrench calibration tools improves product quality.

Don’t Get Hit with Costly Product Failures: Use Torque Wrench Calibration Tools

Improving your process improves your profitability. In assembly, accurate torque tools enable companies to tighten their fasteners correctly, preventing product failures on the line and after delivery. If torque tools slip out of calibration, however, that may affect production. By developing a calibration plan and investing in the right tools to carry it out, companies…

It's important that you think ahead when planning for torque tool calibration.

Planning Your Torque Tool Calibration Procedure Reduces Risk and Increases Process Control

You don’t want to be surprised by a torque tool that is out of calibration. After all, torque tools are precision instruments used to tighten critical, often safety-sensitive fasteners. When these tools are out of calibration, products can be made incorrectly, possibly even failing in the field. So, when a torque wrench is out of…

It's important that medical device manufacturers meet ISO certifications.

Medical Device Producers Meet ISO 13485 Requirements with Quality Fastening Systems

The centrality of quality management in medical device production cannot be overstated. For that reason, the production of medical devices is heavily regulated across the world, falling under the jurisdiction of various national and international bodies, such as the U.S. Food and Drug Administration and the European Commission. To help companies comply with this international…