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Hartford Technologies Blog

Key Regulatory Requirements In Medical Manufacturing

Posted: Mar 15, 2017 4:23:36 PM

The highest of manufacturing standards are required of companies who manufacture medical devices. A patient’s health and wellbeing is the prime reason for this. That’s why the specialty ball bearings, pins, and customized bearing assemblies used within these medical devices are held to the highest possible standards. At Hartford Technologies we're proud to uphold standards set by the FDA and World Health Organization. To follow is a review of two of the top regulatory requirements that must be met by medical manufacturers:

1) Cleanliness Standards in Manufacturing

No industry has higher cleanliness and sanitation standards than the medical industry, and for good reason. Many of the components inside medical machinery and devices are often either in direct contact with the patient or in direct contact with the fluids and medications they are being administered. With this being the case, it is especially important to ensure that any part manufactured for use in medical equipment is done so with extreme care and attention. Among other things, this means frequent, routine inspections of all medical manufacturing machinery and workspaces to make sure they are kept completely clean and sanitary. Each part manufactured is stored in a sterile environment, and contact with outside sources is kept to an absolute minimum. From the very beginning of the manufacturing process to the final inspection before the products are shipped out of the factory, medical manufacturers are required to keep all medical device components being used in medical machinery completely free of contamination. It is a standard that Hartford Technologies is proud to uphold.

2) Quality Control Standards in Manufacturing

It's never good if a part fails. Particularly in a medical device being used to treat patients.  Impeccable quality control is critical. One flawed  part could end up impacting a life. One of the most horrific examples is the story of a company that manufactured a cement that could be injected into bone. Due to poor quality control and a refusal to listen to direct orders from the FDA, this product ended up costing at least five patients their lives. Ball bearings, pins, and customized bearing assemblies used within these medical devices undergo multiple inspections and are built with a number of fail-safes that effectively eliminate any chance of that part malfunctioning. At Hartford Technologies, we recognize that lives depend on the parts we manufacture, and this is a responsibility we treat with the respect and serious commitment that it deserves.

Conclusion

There is a lot required of any company manufacturing for the medical industry. The regulatory requirements from various governing bodies work hard to ensure these parts are held to highest possible cleanliness and quality standards. At Hartford Technologies, we are glad these standards are in place. Our goal is to not only meet these standards but to go above and beyond them at every possible opportunity. If you would like to learn more about any of the precision balls, precision pins and rollers, customized bearing assemblies, and other bearing parts we manufacture for use in medical machinery, feel free to contact us today.