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Every organization that manufactures medical devices, pharmaceuticals, biologics, cosmetics, or other types of products that are regulated by the FDA or similar bodies are required to have a Quality Management System (QMS). Some systems, like those for medical devices, need to be more complicated, while others, like those for cosmetics, can be a bit more simple. Regardless there are basic concepts that apply to every QMS.

The FDA calls the QM requirements they set current Good Manufacturing Practices (cGMP).[1] These practices have been outlined in the CFR part 820 for medical devices.1 Other product QMS requirements are outlined in other parts of the CFR. Having a system that complies with the correct part CFR is the key to getting a product onto the market within the United States. Other countries have similar requirements and regulations outlining them, the European Union outlines their requirements for medical devices in the EU MDR 2017/745.

Simply fulfilling the requirements outlined in these regulations will not mean that a company’s QMS is one that actually works well since a QMS should be tailored to the company. At the same time, the QMS also needs to be flexible to adapt to any potential changes the company may experience. As the company grows the QMS should grow with it. A well-made but outdated QMS can end up doing more harm than good.

Documents within the QMS should be easily understood so that any new employee can follow the QMS. Additionally, any forms the QMS contains should be fillable by anyone who needs to. Making the QMS overly complex or forms not easy to fill out will end up hindering quality instead of improving it. That being said, the system should also not be made so simple that it does not meet the requirements of the FDA or any other relevant regulatory body.

It can be hard for a company to develop a working QMS that meets all the required regulations. EMMA International can help develop a QMS no matter what type of product it is for. For both small and large companies EMMA International can provide a full range of Quality Management Services. From ensuring that all the necessary quality systems and procedures are in place to helping maintain post-market compliance, EMMA International does it all. EMMA International provides Full Circle Consulting, give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (September 2018) Quality System (QS) Regulation/Medical Device Good Manufacturing Practices, Retrieved 11/7/2021 from https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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