Marconi Medical Systems as a whole, is a transnational corporation. While retaining its strength in the United Stated, MR's products have achieved global recognition. Strengths in markets such as Europe and South America have opened doors to Asian countries such as Japan and China. MR has a variety of customers, but focuses primarily on hospitals and imaging centers. MR customers expect high quality systems that are easy to use, have low operating cost, high throughput, and can support new technology. An MR system must provide superior image quality and offer a range of imaging techniques to support diagnosis. Given the high cost of the equipment (

The Regulatory Affairs Group prepares and submits all documentation required for FDA approval/clearance of new products and modifications/ upgrades to existing products. The team is responsible for all interactions with government regulatory agencies and Industry Relations (Corporate) Department. It also monitors and follows-up Medical Device Reporting (MDR) requirements and monitors compliance with the Safe Medical Devices Act and other medical device legislation.

In the first stage of the design process, the Product team, with the assistance of the Regulatory Affairs team, determines the regulatory requirements for a product. One of the key requirements that must be considered is if a 510(k) submission is required in order to distribute the product in the United States. The product team leader completes a Regulatory Impact Assessment (RIA) to determine if such a submission is needed. After completing the product information required by the RIA, the Product Team Leader submits the information to the Regulatory Affairs section to determine whether the new product requires a 510(k). If Regulatory determines that a 510(k) submission is needed for one or more features included in the product, the Product Team Leader should incorporate the submission strategy into the design plan for the product. The strategy should include both the number of submissions required for the product (individual features may be submitted separately) and the type of submission to be filed for each feature. Based on the type of feature/product and the needs of the business, the Regulatory group may recommend one of the four types of 510(k) submissions.

 Special 510(k): This type of a submission can be used in cases where there is no change in the intended use of the device or in the fundamental scientific technology of the device. Instead of submitting data to support the submission, the manufacturer submits a "Declaration of Conformity" with the design control requirements in the Quality System Regulations and a brief summary of their design control process. All design control activities and verification/validation tests specified in the Risk Analysis must be completed at the time of the submission. The advantage of this type of submission is that FDA will make a clearance decision in 30 days.

2. Duane Praschan, former Regulatory Affairs manager, Marconi Medical Systems.

Certain components such as blood tubing sets, major diagnostic x-ray components, and stand-alone software are regulated by the FDA as finished devices because they are accessories to finished devices and meet the above definition of a device. Software that is to be marketed to enhance the performance of a device is regulated as an accessory to that device. Software that enhances the performance of a group of different devices is regulated as an accessory to the device that poses the greatest risk to the patient. The manufacturer of accessories is subject to the medical device regulations when the accessory is labeled and marketed separately from the primary device for a health-related purpose to a hospital, physician, or other end user.

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Approximate Word count = 2250
Approximate Pages = 9 (250 words per page double spaced)