Medical Device Courses | Grzegorz Galka | Activity https://medicaldevicecourses.com/members/grzegorzgalka/activity/ Activity feed for Grzegorz Galka. Tue, 26 May 2026 20:04:41 -0400 https://buddypress.org/?v= en-US 30 hourly 2 84f3cea016f277d14f164a8ec64e00d5 Grzegorz Galka replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11379/ Wed, 15 May 2019 16:44:24 -0400 I learned a lot about the medical device industry in this class. At the beginning I was a little scared because I finished my B.S in Chemical Engineering and currently I am working on my M.S in Mechanical Engineering. So,…   Read more»

]]> 6220e1e7530ba936bf5d4fc6de6625dc Grzegorz Galka replied to the topic "Alternatives dispute resolution" - https://medicaldevicecourses.com/activity/p/11378/ Wed, 15 May 2019 16:44:23 -0400 I would like to write a story about the out of court dispute resolution which happened in my company. It would give an idea what mistakes and negotiation can be used in similar cases. So, my company is electromechanical supplier…   Read more»

]]> dc1cef98ed41ccf55803863ab0143cc3 Grzegorz Galka replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/11377/ Wed, 15 May 2019 16:44:23 -0400 NDA (nondisclosure agreement) is a legal contract that protests sensitive information. NDA can be used when new product or design is in developing stage to help the inventor keep patent rights. Properly written NDA can help the inventor hold the…   Read more»

]]> 2c4d2a2e3324b1e0483c39cd14169a4f Grzegorz Galka replied to the topic "Organizational structure and Culture both leading to project success?" - https://medicaldevicecourses.com/activity/p/11279/ Wed, 15 May 2019 16:43:34 -0400 I also haven’t had any experience in a non-welcoming culture myself. I saw a struggle of another Engineer who was shy, quiet and couldn’t make his point. Based on my assumptions the non-welcoming might happen more often in smaller companies…   Read more»

]]> 8ed79e06dace60c199c8df17346cbd90 Grzegorz Galka replied to the topic "Project Management Preferences" - https://medicaldevicecourses.com/activity/p/11243/ Wed, 15 May 2019 16:43:15 -0400 I would desire to work in a Project-based Organization as a PM. Often; the project manager makes the decisions and has whole control over members of project team. I chose it because I will have a lot of more authority…   Read more»

]]> 437f84c4d5bdc0c38d67c100c10f7153 Grzegorz Galka replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11241/ Wed, 15 May 2019 16:43:14 -0400 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…   Read more»

]]> 350b430c640490a5262d8d21ddfeb62a Grzegorz Galka replied to the topic "The change from ALARP to AFAP" - https://medicaldevicecourses.com/activity/p/11168/ Wed, 15 May 2019 16:40:29 -0400 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…   Read more»

]]> a7a22331406ddd7f51bfb1c6b0e33e71 Grzegorz Galka replied to the topic "Risk management methods" - https://medicaldevicecourses.com/activity/p/11161/ Wed, 15 May 2019 16:40:25 -0400 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…   Read more»

]]> 0666f25bdb459d3d90da15a3707dbb79 Grzegorz Galka replied to the topic "Risk Identification" - https://medicaldevicecourses.com/activity/p/11160/ Wed, 15 May 2019 16:40:25 -0400 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…   Read more»

]]> bfb1e965761b9655a245bacce9c3f621 Grzegorz Galka replied to the topic "Combination Product Phase I clinical Studies" - https://medicaldevicecourses.com/activity/p/11012/ Wed, 15 May 2019 16:39:02 -0400 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…   Read more»

]]> 848612fefd57fba0cea9d330c88fb732 Grzegorz Galka replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/11010/ Wed, 15 May 2019 16:39:01 -0400 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…   Read more»

]]> bd55780b1e9cd2e6f3bb8f572ee609a1 Grzegorz Galka replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/10975/ Wed, 15 May 2019 16:38:28 -0400 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…   Read more»

]]> 8cee2683b67752fd193c30d1402f7a83 Grzegorz Galka replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/10915/ Wed, 15 May 2019 16:37:54 -0400 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…   Read more»

]]> e8b83273770b6bea8635deac19848da7 Grzegorz Galka replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10911/ Wed, 15 May 2019 16:37:51 -0400 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….   Read more»

]]> 5ac15a4a3d62f42ba3a58bd62af11fcb Grzegorz Galka replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/10906/ Wed, 15 May 2019 16:37:47 -0400 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…   Read more»

]]> 2a8a5101c71d37abc8352a619242d96f Grzegorz Galka replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/877/ Sun, 04 Dec 2016 06:03:55 -0500 I learned a lot about the medical device industry in this class. At the beginning I was a little scared because I finished my B.S in Chemical Engineering and currently I am working on my M.S in Mechanical Engineering. So, this class was also a little experimental. I wanted to see what’s happening in the Bio-medical industry. Actually, I am happy t…[Read more]

]]> 0 43d288c55fb1159580d4a515daa8582c Grzegorz Galka replied to the topic Alternatives dispute resolution in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/876/ Sun, 04 Dec 2016 05:55:05 -0500 I would like to write a story about the out of court dispute resolution which happened in my company. It would give an idea what mistakes and negotiation can be used in similar cases. So, my company is electromechanical supplier for the US army and many times we make very specific assembly. In this case the estimation was done for the whole BOM.…[Read more]

]]> 0 2f4cf8a36925fe142432c6194fa94c48 Grzegorz Galka replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/875/ Sun, 04 Dec 2016 05:33:25 -0500 NDA (nondisclosure agreement) is a legal contract that protests sensitive information. NDA can be used when new product or design is in developing stage to help the inventor keep patent rights. Properly written NDA can help the inventor hold the rights to the specific product. In case when the product would be presented to the public, the inventor…[Read more]

]]> 0 29385665fd71d558c0cd7707c54e286e Grzegorz Galka replied to the topic Organizational structure and Culture both leading to project success? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/750/ Mon, 28 Nov 2016 00:09:53 -0500 I also haven’t had any experience in a non-welcoming culture myself. I saw a struggle of another Engineer who was shy, quiet and couldn’t make his point. Based on my assumptions the non-welcoming might happen more often in smaller companies with low benefits were people are just unhappy. They pass their frustration on others. I also noticed tha…[Read more]

]]> 0 53c6b5395eee08d2e0f9c1dd2c09d85a Grzegorz Galka replied to the topic Project Management Preferences in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/705/ Sat, 26 Nov 2016 05:57:55 -0500 I would desire to work in a Project-based Organization as a PM. Often; the project manager makes the decisions and has whole control over members of project team. I chose it because I will have a lot of more authority in it. It would be much easier to control the projects and stay on the schedule. The communication with the team will be better as…[Read more]

]]> 0 c4b63fdae1cba9a1c9e16e99f33f64db Grzegorz Galka replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/702/ Sat, 26 Nov 2016 00:37:40 -0500 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]

]]> 0 8a1d96c78e1400faed4fcef9e647c621 Grzegorz Galka replied to the topic The change from ALARP to AFAP in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/613/ Mon, 21 Nov 2016 02:53:16 -0500 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]

]]> 0 93b2c7b1d95d634d64710ecf807709e1 Grzegorz Galka replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/606/ Mon, 21 Nov 2016 02:21:49 -0500 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]

]]> 0 8025a0c883afcfa040598226ccc9cdd9 Grzegorz Galka replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/605/ Mon, 21 Nov 2016 02:04:52 -0500 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]

]]> 0 33fa5f8bb5dc3d8dfe318e8e4aadbc12 Grzegorz Galka replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/411/ Sun, 13 Nov 2016 23:50:46 -0500 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]

]]> 0 72168f34b2aa1f5bfa62525f3d46d924 Grzegorz Galka replied to the topic When is validation is not required? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/409/ Sun, 13 Nov 2016 23:29:45 -0500 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]

]]> 0 577fb007290206fa6cbf57ba909302b6 Grzegorz Galka replied to the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/353/ Fri, 11 Nov 2016 21:02:42 -0500 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]

]]> 0 f3fdf93f60d48edf09366fdc100d3483 Grzegorz Galka replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/272/ Mon, 07 Nov 2016 03:56:26 -0500 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]

]]> 0 0fe0f567a5590ef6f6d5fc3d1f1ce811 Grzegorz Galka replied to the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/266/ Mon, 07 Nov 2016 03:31:56 -0500 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]

]]> 0 7c44e0dd9e4e866f714e75103342d3b1 Grzegorz Galka replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/260/ Mon, 07 Nov 2016 03:19:49 -0500 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]

]]> 0 914bc712d55d1bd2187b8e94831e013d Grzegorz Galka became a registered member https://medicaldevicecourses.com/activity/p/256/ Mon, 07 Nov 2016 03:06:30 -0500 0