How to Improve Quality in Medical Device Manufacturing

Medical devices sold in North America are subject to the highest standards and requirements in the world. Medical device manufacturers need to adhere to guidelines during every stage of the process, from registration to labelling. In addition to this, inspections by officials are regularly conducted to enforce these regulations, and manufacturers are subject to steep penalties if they are found to be non-compliant.

When it comes to manufacturing, precision is of the utmost importance, and manufacturing medical devices is no exception. For the medical device to provide accurate testing and diagnostics, every fastener and joint need to be tightly connected, signals need to pass through at the right wavelengths without any interference and encounter the exact resistance.

This need for exact precision is why manufacturers depend on the accuracy of the tools used during the medical device manufacturing process.

Are you looking to ramp up production on your medical devices but struggling to optimize a new manufacturing process? This can be a massive challenge for medical device manufacturers. Medical devices are complex to assemble, requiring various speeds, angles, fasteners and assembly delicacy.

Manufacturers of sophisticated medical devices face these challenges on the production line:

• Multiple torque requirements
• Risk of cross-threading
• Risk of over-tightening
• An incredibly complex assembly that requires multiple tools
• Issues with quality assurance due to required speeds
• Multiple angles and fastener delicacy

The Importance of Torque Calibration in the Medical Manufacturing Industry

Regularly scheduled torque tool calibration will ensure repeated accuracy and adherence to international standards to manufacture medical devices. Ongoing torque calibration guarantees that your equipment is operating at its best because it highlights potential problems before they become a real issue.

The pressure to deliver quality medical devices is increasing, and companies are continually looking for solutions that can better ensure the quality of their manufacturing process. When it comes to torque, devices like the DRTQ Touch Screen Torque Tester offer invaluable benefits.

Electronic torque testers can offer high accuracy. They are also reliable and easy to use. These types of torque analyzers can offer the user much more than just torque calibration. Most digital torque calibration equipment can allow the user to download test results, test hand and power tools, select a wide variety of different measurement units, and carry out calibration beyond the scope of medical calibration devices.

Torque Control in Medical Device Manufacturing

A majority of medical devices require the use of fasteners when assembling them. For each of these fasteners, you’ll need to determine, apply and verify the appropriate amounts of torque for each fastener. Depending on the classification of the medical device you are manufacturing, there may be more rigorous standards for repeatability. All medical devices need to meet different torque requirements and various speeds, angles, and fastener or component stress and strain tolerances.

There are three areas where measuring torque is critical during the medical device assembly process:

1. Before assembly

Torque testing equipment is used before assembly for tool setup or for conducting tool capability studies. Technicians need to ensure that every tool can provide the necessary torque and repeatability required for its intended application.

2. During assembly

During assembly, torque testing equipment is used to audit the tool and verify whether the torque is being applied correctly or if the device is starting to wear out. Using this information, technicians can easily make any necessary adjustments to the tool or the assembly process.

For hand tools like torque wrenches or torque screwdrivers, technicians and manufacturers can use a DRTQ Touch Screen Torque Tester on the production floor. Users can use this torque tester to verify the torque setting daily or weekly to ensure that their tools do not fall out of calibration.

3. After assembly

Torque testing can be used as a final quality check. Manufacturers might choose to authenticate the torque after the assembly process to verify that the adequate torque was delivered to all fasteners. They are also able to detect any missed or loosed fasteners, as well as joint relaxation.

As you can see, by using a torque testing tool like the DRTQ Touch Screen Torque Tester, you can boost quality control efforts when manufacturing medical devices. Precision torque control is vital within the medical device manufacturing process and all assembly lines in general. Producing life-saving medical devices requires the utmost care in ensuring the correct torque is being used.

It is critical to choose manufacturing tools that deliver precisely controlled torque to every fastener holding medical devices together. The failure of a three-cent fastener can lead to catastrophic losses. Fasteners that insufficiently torque can and will vibrate loose. And the use of excessive torque can lead to strip-threaded fasteners.

Using quality torque testing tools like the DRTQ Touch Screen Torque Tester is critical for manufacturers, especially those in the medical device industry. Regular testing and calibration are necessary despite technological advances in fastening tools. All tools experience wear and tear over time due to friction, vibration, abuse and fatigue, negatively affecting the torque calibration of even the most advanced tools on the market.

Torque testers are needed as a traceable reference to verify the tool’s accuracy. These devices help to maintain proper tool torque so assemblers can achieve repeatable and error-free fastener installation.

To learn more about torque testing tools, call Delta Regis Tools at 1-888-500-2755 or contact us here.