Compliance and quality, while similar, can also be strikingly different. Many companies treat quality as nothing more than a box to tick. Something that must be done in order to meet the regulatory requirements set by the regulatory body of the market they are trying to sell in. This, however, is a flawed way of thinking. Simply being compliant with regulations does not mean that an organization has a Culture of Quality.

Truly having quality in an organization is a lot different than simply checking a box. It is about fostering that drive for improvement, about encouraging every employee, from the CEO down, to produce the best possible products.  If a company simply follows the rules set by a regulatory body, it will fail to create that drive for improvement. The organization will still produce a product that is acceptable for the market, but it will not create a quality product.

Being compliant is important, it is necessary for a product to even get to market. An organization that is compliant with regulations will produce a product that is safe and effective, which is the goal of regulators. Being compliant may even mean having a robust, well-made, quality system in place. On the flip side, a company that is only compliant and cares little for quality will be likely to have a poorly made quality system, one that was made to simply check that box. It is unfortunate that this is the case across many organizations.

This is not to lay blame on organizations. Being compliant with all the necessary regulations is a challenge in and of itself. Even when an organization may think it is compliant those regulations are subject to changes meaning that the organizations will have to make rapid adjustments in order to once again be compliant. Organizations should, however, always strive to rise about the challenge of simply being compliant and become an organization that is based on true quality.

Having a well-made quality system, capable of growing and evolving alongside an organization is a key first step to creating true quality. EMMA International is capable of building that quality system, ensuring that is tailored to the exact needs of an organization, and helping to teach employees how to use the system. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


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.

More Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

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