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Change Standards. Achieve Excellence. Qualitas.

 

 

Qualitas Professional Services, LLC

 

 

Quality Systems

 (including ISO, CFR, MDR)

UDI

Regulatory Compliance

Why us?

Quality starts with a quality mindset. It grows with attention to detail and persistence.
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Qualitas Professional Services strengthens growing companies that have tremendous opportunities but need help in harnessing them. We work side by side with you, truly as partners, to create manageable systems that continue to deliver results long after we’ve left.

Qualitas Advantage

Success is the result of planning and process. It is a constant cycle of identifying opportunities, rising to challenges, and reshaping the future.

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Qualitas: Your Quality SWAT Team.

Give us an assignment. Let us help you identify your “Point B” so we can get you there. Contact us to move in the right direction.

From chaos to composure

In the beginning, the workers in a small business wear many hats. They create their way of doing things. As the company grows, more people join and bring their systems, processes, forms, and ideas. Someone leaves, and others scramble to fill in the gap of how to approach the tasks. Until you regain composure, you lose productivity—even compromise customer satisfaction. Before long, your company is pieced together from disjointed methods. Is this the vision for your growth?

Are you UDI compliant? Are you sure?

Medical device manufacturers are required by the FDA and EU MDR to provide item-level traceability. If you don’t comply with the labeling requirements, you risk mislabeling your product and cannot sell your products in the United States. Click here to ensure you’re fully UDI-compliant.

Learn the ROI of ISO certification.

Achieving ISO 13485:2016 requires commitment. What do you get for the return on your time investment? Click here to learn why ISO certification matters to your business.