FAQs

Frequently Asked Questions

Quality Management Systems

Why do we need a Quality Management System?

A Quality Management System provides a carefully planned framework to achieve scalable, repeatable results. When you implement QMS, you ensure that your organization’s goals and visions continue, in spite of changes in staff. The procedures laid out in QMS establish a roadmap for present and future processes, keeping everyone on track with meeting or exceeding expectations.

A QMS also enables you to easily prove conformance with the regulations that govern your business or industry. In the event of an audit, the systems in your QMS allow you to quickly access the necessary documentation.

Most of all, the quality that you infuse in your products, people, and services are ultimately reflected in the customer satisfaction you receive. “Quality” isn’t an expense. It’s an investment.

How long will it take to launch a QMS for us?

Any total quality management system requires careful assessment, the development of results-based systems, documentation, testing, and training. Qualitas takes a PDCA approach (Plan-Do-Check-Act) to build and implement your QMS. While we can expect to launch the program in 6 to 8 months, depending on your organization’s support, this system in a “living process”. It enables growth but also grows with your changing needs. Layer by layer, your QMS builds a solid structure.

We look at Qualitas as your Quality SWAT Team. We tackle the challenges that are most important. Then, we keep moving forward as you see fit.

How much will it cost?

This question is like asking, “How much will it cost to go out to dinner?”

It depends. Do you want a quick, casual meal, or a five-course, five-star experience? Our pricing is designed to be affordable while also reflecting the in-depth attention to detail that we use to ensure you do, indeed, achieve total quality, not a flawed version.

Do you do it all at once or can we tackle this on a project basis?

We start with an overall assessment of your organization’s situation. Then we focus on the systems that will deliver the most impact on your most pressing issues.

Some people consider the act of hiring a consultant as an open-ended engagement. Because we have established our own quality system, Qualitas has key performance indicators that we use to measure our own effectiveness. These KPIs keep us focused on what you’ve hired us to achieve. Use us for projects or engage us for the total QMS. It’s your choice. We’re here to help.

What kind of deliverables do you provide?

We are sticklers for detail. We thrive on documentation. You will receive a gap analysis that details areas in your organization that present risk of error. We work through a process we call “Inclusion/Exclusion”, and present the findings to you.

Qualitas believes that strong communication fuels successful outcomes. We communicate with your leadership team every step of the way, providing the report on the schedule that best suits you. We submit reports and documentation for approval. This fully collaborative approach has proven to build understanding and acceptance throughout the process, making it easier to deploy and adapt.

UDI Compliance

Isn’t UDI compliance just getting the right information on the label?

Unique Device Identification was established by the FDA to properly identify a medical device throughout its distribution and use. Compliance relies on the label, but getting to this output requires collecting and processing the correct data (including GUDID filing), using software and hardware that produces compliant labels, and establishing an internal system that guides the process.

How can we be sure we’re complying with the FDA’s mandate for UDI?

You need to ensure that you have compiled and properly submitted the correct data, and then developed the labeling system that meets with the standards. Qualitas starts by assessing your situation so we can build the solution that ensures complete compliance.

We have been integrally involved with the UDI mandate since it was launched in September 2013. With almost a decade of experience working with medical devices prior to UDI, we have a strong foundation in medical device manufacturing, distribution, and use. Our UDI compliance expertise isn’t just an extension of a compliance consulting practice, but the result of our commitment to the industry.

Qualitas has a license for the Global Medical Device Nomenclature (GMDN) database and can help identify the GMDN code that is appropriate for each of your medical devices.

We also have memberships with the Association for the Advancement of Medical Instrumentation (AAMI) and the Regulatory Affairs Processional Society (RAPS), as well as actively participate in the standards development process with the International Organization for Standardization (ISO).

What are the consequences if we don’t comply with UDI requirements?

The consequences vary—from a fine to a total product recall to being prohibited from distributing your devices within the United States.

 

Do you have more questions? Contact us to get the answers you need.