Quality Management Systems that CLIC™

by | Jun 11, 2021 | Medical Devices, QMS, Quality, Quality Systems, Regulatory, Tools, Validation

          While a Quality Management System (QMS) is a necessary and foundational element of any life-science organization, it does not come without its own set of headaches and frustrations. If you were to survey people from your team, chances are they would have at least a handful of complaints or ways to improve your current QMS. Whether it is a CAPA process that is easily over-burdened, a complaint management system that is inefficient, or a change order process that is just a documentation blizzard, QMS’s are meant to be optimized for your organization, not drain its resources.

EMMA International’s proprietary methodology, CLIC™, ensures that we help you implement a QMS that is Compliant, Lean, Integrated, and Customizable. We optimize our CLIC QMS systems to fit your operation, ensuring your QMS not only complies with ISO, GxP, and all other applicable standards, but helps you develop safe, effective products. Our methodology has proven to be sustainable, easy to follow, scalable, and cost-efficient for our clients. CLIC can be tailored to your business needs, scaled to the size of your operation, and needs minimum resources to maintain ongoing compliance.

No matter if you are a start-up medical device firm, or a multi-national pharmaceutical manufacturer, having an optimized QMS is a must. I have seen nightmare scenarios of organizations with a QMS that does not fit their operations, which ends up being draining on both time and human resources.

The most common sub-systems that can quickly become out of control for an organization include CAPA, Complaint Management, Supplier Management, and Change Control. It is important to follow the Goldilocks principle when it comes to quality systems processes; not too much and not too little. You do not want a process that is more complicated than you need putting strain on your resources, and you don’t want a process that is not robust enough causing you to be out of compliance. With our CLIC methodology, we can implement a QMS that is truly “just right” for your organization.

Whether you need a QMS built completely from scratch, or just need an expert set of eyes to assess areas for improvement, EMMA International can help! Our quality systems experts are available 24/7 to support whatever your needs may be. With cost-effective solutions that are sustainable for your organization, you can rest assured that EMMA International has you covered. Give us a call at 248-987-4497 or email info@emmainternational.com to learn more.

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
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.

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