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Grzegorz Galka replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies 7 years, 5 months ago
It’s very important to get the right people to perform good project team. We need to evaluate the professional performance as well as human qualities. Many times we cannot choose who will join our team. If it’s possible we should pick a people who are knowledgeable and work well in teams. It is the role of Project Manager to observe who works wel…[Read more]
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Grzegorz Galka replied to the topic The change from ALARP to AFAP in the forum Risk Analysis for Medical Devices 7 years, 6 months ago
Medical device manufacturers cannot depend on procedures to decrease the risk as they used to do in the past. Additionally labeling must be still shown on the medical devices, but it cannot be longer used to mitigate risk. The idea of decreasing risk as low as reasonably practicable (ALARP), which contains economic concerns, was swapped with an…[Read more]
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Grzegorz Galka replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices 7 years, 6 months ago
The CAR (corrective action) would be a good method to manage the risks. I had a chance to send few of them to the vendors when they send defected materials to my company. The corrective action gives the other company information that something is incorrect. By fixing their problems the risk that their material will be defective again will…[Read more]
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Grzegorz Galka replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 7 years, 6 months ago
Currently I work in the company which supplies US Army with mechanical equipment. Some portion of my job is to look for the solicitation. By looking on the solicitation and doing the basic estimation you can figure out how risky the future contract can be. So risks are prioritized based on the possibility of not being able to complete the…[Read more]
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Grzegorz Galka replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls 7 years, 6 months ago
Hi,
During the phase I clinical trials we can find out if the drug or medical device is safe to for people. In this initial phase of clinical trials small group of people is tested for couple of months. In most cases it is a group between 20 and 100 healthy volunteers who are receiving money for being part of the study. The study is intended to…[Read more] -
Grzegorz Galka replied to the topic When is validation is not required? in the forum Introduction to Design Controls 7 years, 6 months ago
Hi,
It’s very important to do the human factors evaluation. It shows the interactions between the device and the user. It’s performed to make some manipulations to the device and perhaps replace some components. It is crucial when we want to know the interference between the user and medical device. When human factors are considered the dev…[Read more]
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Grzegorz Galka replied to the topic Design Review Meetings in the forum Introduction to Design Controls 7 years, 6 months ago
Hi,
I never attended design review meeting. Although it’s very similar with other meetings summarizing activities during a project. It’s very important to meet while the milestones are done to review the situation. During the design review meeting people can meet face to face and ask questions. It’s very important that everyone who is worki…[Read more]
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Grzegorz Galka replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 7 years, 6 months ago
Hello,
There are many consequences of the insufficient design control. The design control must contain different stages such user need, design input and design output. User need is important because we need to know what the user expects. For the design inputs we must know what this product will do. In the design output we must figure out the way…[Read more]
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Grzegorz Galka replied to the topic What are Design Controls? in the forum Introduction to Design Controls 7 years, 6 months ago
Design Control is a set of management practices such as procedures, processes and policies. They have to be followed to ensure proper quality and to correct any errors during the product development. Medical devices must meet quality and safety standards. Otherwise these products might be called for recall due to design problems. The recall can be…[Read more]
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Grzegorz Galka replied to the topic Design Verification & Validation in the forum Introduction to Design Controls 7 years, 6 months ago
Validation and verification are very similar.
Verification is performed to check if the design follows to specifications by verifying the documents and the design. Verification uses different methods such as reviews and inspections. In this case the person checks the documents and the files. It can catch errors that cannot be found by doing the…[Read more] -
Grzegorz Galka became a registered member 7 years, 6 months ago