Topic 1

How to protect Patient safety?

MRA and its Founder, Mr. Quinn, began work in 1994 to understand and apply the regulations enacted to protect Patients against the inherent dangers of medical devices that were in force since 1968 but never widely used or understood by our community.

MRA began working with responsible Original Equipment Manufacturers (OEM's) to begin the process of resolving issues of regulatory compliance by OEM's and others, (Assemblers, Servicers, Installers and others) to better protect patient safety.

Today, most but not all OEM's are complying with the regulations and all of MRA Providers have a compliance program that meets or exceeds regulatory requirements.

By OEM's and others complying with the regulatory requirements Patient safety is protected.

Topic 2

How to lower the costs of medical devices by complying with regulatory requirements?

The natural outcome of understanding and complying with the regulatory requirements placed on OEM's and others is an increase in the competition for after warranty services needed to assure medical devices meet performance and installation requirements.

With an increase in competition for after warranty services and the knowledge of regulatory requirements for the services needed for medical devices after warranty, Members can lower costs and improve Patient safety.

In the event a Member elects to purchase a pre owned medial device, complaince with the regulatory requirements assures that the device will meet installation and performance requirements by installer no matter who installs the device.

Topic 3

By complying with the regulatory requirements are my liabilities reduced?

The regulations contain limited liability protection for OEM's, Assemblers, Servicers, Installers, Users and others.

Members can reduce their liabilities by using the same regulations in the purchase, warranty, after warranty service, disposal and by using the regulatory reporting available to users and owners.

Members can also reduce their liability and non complaince with HHS, Medicare and Medicaid, MQSA, State regulations and rules and accreditation, by using the regulatory requirements to resolve issues.