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 actions, and recordkeeping. Modern torque tools and assembly systems are an integral part of ensuring that manufacturers meet or exceed the demands of FDA 21 CFR Part 820.
Understanding the Requirements of FDA 21 CFR Part 820
There’s no room for error in medical device manufacturing, which is why the FDA has laid out stringent rules for each step of the manufacturing process, from ideation to post-production. As a starting point, the FDA requires that each company manufacturing medical devices develops and implements a quality system to ensure that devices are free from defects. The further requirements of part 820 can be read as a roadmap to implementing this quality system.
As part of their quality system, manufacturers must establish controls on the designs of their devices, the procurement of all parts and services which will make up the device, and any documents which must be produced with the device. In addition, manufacturers must be able to identify each individual device. In the case of medical devices which are critical to the lives of patients, such as implantable devices or life support systems, manufacturers must also be able to trace the device back through production.
You will need to strictly control, monitor, and document the actual production process of each medical device to prevent mishaps, defects, or contamination, and to ensure that each product is manufactured exactly as designed. The methods of doing so must be documented in standard operating procedures or other defined instructions. Manufacturing equipment must be maintained on a regular schedule, equipment and products must be inspected continually, and all inspection equipment must itself be tested and calibrated in conformity with national or international standards.
Finally, manufacturers must follow procedures for accepting finished products, rejecting products which do not meet standards, and work proactively to identify, correct, and prevent future quality issues. Labels must be affixed in a way that is legible and correct. Controls should be implemented in each stage of handling, distribution, storage, and installation to ensure that products go where they need to go without suffering harm along the way. If service is required, the manufacturer must develop and verify service procedures. Of course, you need to keep thorough records for every stage of the process. For more detailed information on any regulatory requirement, consult the Code of Federal Regulations and legal counsel.
Using Torque Tools to Comply with FDA 21 CFR Part 820
Torque tools are essential equipment for any company producing medical devices with threaded fasteners, such as screws or bolts. As part of each device’s design, all fasteners included in the device will have a proper torque value specified. In order to ensure that torque requirements are met, manufacturers must use tools which can detect and limit the amount of torque applied to each fastener. By investing in torque tools for production, companies can implement proper process control measures.
Hand tools—such as torque screwdrivers, break-over wrenches, and cam-over wrenches—possess the needed specificity to appropriately tighten most fasteners used in medical devices. For devices which require strict environmental controls to prevent contamination, screwdrivers designed for clean room environments are ideal. However, power tools are often the correct choice for medical device manufacturers since they are faster than hand tools and provide built-in documentation.
In order to meet maintenance requirements, manufacturers must test their torque tools regularly, either using in-house torque testing equipment or by shipping their tools to certified service centers on a rotating basis. Using in-house testing equipment can significantly increase tool uptime, but that route places the onus of inspecting and calibrating test equipment upon the manufacturer. Fortunately, you can purchase inspection and calibration equipment with torque testers and analyzers, making it possible to perform and document your own inspections.
Manufacturing medical devices is a complicated and difficult undertaking, subject to close oversight, strict requirements, and severe penalties for negligence. Understanding the codes which govern the production of medical devices is an important first step towards achieving success in this field. For any medical device constructed using threaded fasteners, torque tools are an irreplaceable means of production.
Mountz, Inc. has been a leader in accurate, effective torque solutions for over fifty years. To see our full range of products, browse our catalog. Contact us anytime to ask a question. To ask about price, request a quote. If you’d like to see our equipment in person, schedule an appointment.