OCTOBER 20248In My OpinionQUALITY IN THE WORLD OF MEDICAL DEVICE CONTRACT MANUFACTURINGStacey Lyons, Plastics Quality Director, BiomericsByHaving an effective quality management system (QMS) is required for any medical device company. Having a focus on the safety, function, and efficacy of the product you manufacture is how you are successful within your QMS. The regulations of the Food and Drug Administration (FDA) and International Standards Organization (ISO) will require your compliance to be able to manufacture medical devices. FDA and ISO standards are written clearly but with little detail as to the `How-To's' of applying the standard. There are many guidance documents and white paper guidelines that can help with the application of the standards. The most important guideline to creating an effective QMS is assembling the proper quality group for ideal support of the QMS. Creating your QMS and quality group to fit your organization and device is pivotal. In my experience, your QMS systems are primarily based around branches, with your systems spread across the branches. If you can assign branches and systems within your company properly, it allows you to organize what is needed to follow the regulations. The branches and systems of the QMS can be defined no matter the size of the organization or the class of device. When it comes to branches, bucketing your group into quality systems, quality engineering, and quality control can allow you to isolate your systems and become more effective.
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