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Training on Risk Based Validations

GRS has been invited to provide training for the North County ASQ group on August 11, 2010. It is our honor to come in and discuss this topic, one of our favorites. The discussion will be high level and designed to provide a general overview of implementing a risk based approach to software/medical device validations. We look forward to seeing you there.

Wireless in Medical Devices

Wireless communications are becoming widely utilized in modern medical devices, and with this trend, the FDA is growing concerned about the possible safety impacts that may be inherent with these devices. In response to this growing concern, the FDA has issued a draft guidance document. The intent of the guidance document is to help manufacturers understand their "current thinking" related to these concerns. However, as with most FDA Guidance documents, the content can be a little confusing and intimidating.

Having helped several companies obtain their 510(k) clearance for medical devices containing wireless technologies, we have found several methods for addressing these concerns efficiently. Let us show you how.
The FDA’s guidance on Radio-Frequency Wireless Technology in Medical Devices can be found here.

Recent Recalls

Recalls can be very costly for companies in several ways. Not only does the manufacturer have to pay for the products and repairs, but it also damages the company image and reputation. If not handled correctly or timely, these can also result in Consent Decrees, which few companies are capable of recovering from. Taking the time to incorporate a risk based approach to not only the design process, but also in the manufacturing process can help you avoid these very costly mistakes. A recall does not have to be as painful as this, and we can assist you with conducting the recall. Read about the Baxter recall here.

Though unforeseeable problems do occur, we can help you avoid this process by implementing a risk based approach to your processes. This will not only result in a more streamlined process which is cost effective to implement and follow, but it will also allow your organization to potentially detect fault conditions earlier in the process and stop a recall before it is required.

Infusion Pumps

According to this Draft Guidance for Infusion Pumps found here, 62% - over 34,000 MDR’s were submitted due to malfunctions. Examining these MDR reports, most of these are due to fairly simple design flaws that should have been detected in early phases of design controls and validation. Making use of a Risk Based approach will help you focus your testing efforts on areas where you are most likely to detect issues before they reach the customer.

This guidance document also mentions several elements that may be of primary concern to the manufacturer, but many of these elements can be quite confusing to manufacturers. We can help you implement these areas of concern in ways that make sense to your organization and also help alleviate the FDA’s concerns for your device.

Having completed several 510(k) submissions, we understand what the FDA is expecting to see, and can apply our experiences to your device and process.