Medical Device Courses | fo3 | Activity https://medicaldevicecourses.com/members/fo3/activity/ Activity feed for fo3. Fri, 24 Apr 2026 22:39:12 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b9226b469e747f562c06b90c9e3aaf1e fo3 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11344/ Wed, 15 May 2019 16:44:05 -0400 There can be some confusion with the use of the word “verbal”. A verbal contract can include any agreement with words, which includes both oral and written agreements. Therefore, it’s best to compare between spoken oral contracts and on-paper written…   Read more»

]]> 52df644010910ff84cab268225bb37fc fo3 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11337/ Wed, 15 May 2019 16:44:01 -0400 I feel like the only course in undergrad that introduced industry-related topics was capstone, since it involved working on a project from start to finish and all its deliverables. However, since this was just an intro course, it was very…   Read more»

]]> ffe1f0ffd3f5c784321d51f623812108 fo3 replied to the topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/11209/ Wed, 15 May 2019 16:42:57 -0400 If I was to start a company that worked on a world-scale, the worst thing to form is an organic structured organization, in my opinion. A company working globally needs to have a rigid structure so everything can run smoothly…   Read more»

]]> 83f5ba682cbcf12ebc7489f3aa6f64a8 fo3 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11206/ Wed, 15 May 2019 16:42:56 -0400 In my company, I work in a project-based/matrix-based combination of an organization. There are multiple projects going on at a time and each project has it’s team. However, the teams are made up of staff from different departments (R&D, regulatory,…   Read more»

]]> 363d8bee11ed8d51ee1b69c9c82c6d4c fo3 replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/11159/ Wed, 15 May 2019 16:40:24 -0400 In my opinion, I think a major mistake would be to assume that one is only looking for extreme and catastrophic risks and therefore overlooking risks that are also important. For example, there are risks due to safety that one…   Read more»

]]> f15bd3006cf3efe5bee675679f0aab58 fo3 replied to the topic "Factors Contributing to Risk Values" - https://medicaldevicecourses.com/activity/p/11158/ Wed, 15 May 2019 16:40:24 -0400 It is important to distinguish the types of risks you are analyzing. For example, there are risks that impact business, those that impact manufacturing, and the obvious risks with the device itself. A risk may be considered “high” level because…   Read more»

]]> 91d19d3a8206804081e2eea702dba6d7 fo3 replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/11155/ Wed, 15 May 2019 16:40:22 -0400 I agree – There comes a point where the company has done their part by putting warnings on labels and the customer who is using the device is responsible for following those instructions. For that to happen, it is expected…   Read more»

]]> 280de0dc70a2c82bda7cc321425a686e fo3 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10991/ Wed, 15 May 2019 16:38:37 -0400 Deepthi, yes it is a common practice to keep these inputs and specs in an excel spreadsheet as part of the Design Requirements Matrix (DRM). This document may even be a live document that can only be seen by those…   Read more»

]]> 03886f495eaeb67af09dac340fa1a423 fo3 replied to the topic "Making up tests for design verification and validation" - https://medicaldevicecourses.com/activity/p/10989/ Wed, 15 May 2019 16:38:36 -0400 As we have learned and many have already mentioned, verification tests come about from the design specifications in the DSD. Each specification can have a test linked to it and will be explored during verification. However, not all specifications have…   Read more»

]]> 8a77f064860e89b89af81ed9f2f00d49 fo3 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/10988/ Wed, 15 May 2019 16:38:35 -0400 I’ve realized several things about Gantt charts in the industry. The plan laid out by Gantt chart should be followed as close as possible, especially since projects have deadlines to be met. However, one has to consider there will be…   Read more»

]]> cfb8169790d7cfc1be517ea89976285d fo3 replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/10843/ Wed, 15 May 2019 16:37:06 -0400 There are major differences between design verification and design validation. For one thing, validation always occurs after verification, and in some case may not be required at all. Verification tests the specifications of the device separately, while the validation stage…   Read more»

]]> 10b27893762e16266a4765efbfba2fe3 fo3 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10842/ Wed, 15 May 2019 16:37:05 -0400 When developing an inputs document for a new product it may be a challenge to obtain or come up with the inputs and specifications. As mentioned in the lecture, R&D engineers may help support this by performing development tests or…   Read more»

]]> 46bc5ccc4b8ea3406ae78d093f472a30 fo3 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/10820/ Wed, 15 May 2019 16:36:53 -0400 I agree that there exists an advantage to have the entire design process documented in a DHF versus a snapshot of the design process with the Design Dossier or Tech File. For one thing, we are able to see every…   Read more»

]]> 2a0fdb4ea00a917c82875ee5e55b3356 fo3 posted a new topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/10418/ Wed, 15 May 2019 16:33:25 -0400 As learned this week, it is important to protect our ideas and inventions and to do so in the appropriate legal manner. Part of the lesson discussed Non-disclosure agreements, or contracts, and how they can help protect our ideas. Based…   Read more»

]]> 283d80e4b560cba30a789875073bfa87 fo3 posted a new topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/10410/ Wed, 15 May 2019 16:33:21 -0400 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project according to their expertise/role. How would you best form…   Read more»

]]> 6f76217d5f78ef343878eaecc2e90ef8 fo3 started the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/828/ Thu, 01 Dec 2016 15:08:20 -0500 As learned this week, it is important to protect our ideas and inventions and to do so in the appropriate legal manner. Part of the lesson discussed Non-disclosure agreements, or contracts, and how they can help protect our ideas.

Based on what we know about patents, is an NDA a substitute for a patent? What is the difference between the two,…[Read more]

]]> 0 c7a2d13a9cb03670e2ec7ca4802b30a4 fo3 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/827/ Thu, 01 Dec 2016 14:08:55 -0500 There can be some confusion with the use of the word “verbal”. A verbal contract can include any agreement with words, which includes both oral and written agreements. Therefore, it’s best to compare between spoken oral contracts and on-paper written contacts. One should rely on written agreements, especially for the proof that is guaranteed to…[Read more]

]]> 0 786e8dd755e70a9fea7a9675b5350226 fo3 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/819/ Wed, 30 Nov 2016 19:45:09 -0500 I feel like the only course in undergrad that introduced industry-related topics was capstone, since it involved working on a project from start to finish and all its deliverables. However, since this was just an intro course, it was very important for me that I took a course that further discussed these topics. I went into my first job still…[Read more]

]]> 0 786e8dd755e70a9fea7a9675b5350226 fo3 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/818/ Wed, 30 Nov 2016 19:45:09 -0500 I feel like the only course in undergrad that introduced industry-related topics was capstone, since it involved working on a project from start to finish and all its deliverables. However, since this was just an intro course, it was very important for me that I took a course that further discussed these topics. I went into my first job still…[Read more]

]]> 0 bcb5d7ca890d751bb53c0f5847913bbd fo3 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/817/ Wed, 30 Nov 2016 19:45:09 -0500 I feel like the only course in undergrad that introduced industry-related topics was capstone, since it involved working on a project from start to finish and all its deliverables. However, since this was just an intro course, it was very important for me that I took a course that further discussed these topics. I went into my first job still…[Read more]

]]> 0 95a97d973d15815790af7162d670eec1 fo3 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/665/ Wed, 23 Nov 2016 14:35:36 -0500 If I was to start a company that worked on a world-scale, the worst thing to form is an organic structured organization, in my opinion. A company working globally needs to have a rigid structure so everything can run smoothly and avoid a mess. Organic structures are more for smaller companies, I believe. According to the link given above, the…[Read more]

]]> 0 c1c3fa91c1eb541026371ebca4921365 fo3 started the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/661/ Wed, 23 Nov 2016 14:03:28 -0500 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project according to their expertise/role.

How would you best form a project team, and what mistakes would you try to avoid? For example, is it better to work with people who…[Read more]

]]> 0 bb07b33a23f2a3012206220b2271b65a fo3 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/660/ Wed, 23 Nov 2016 13:44:51 -0500 In my company, I work in a project-based/matrix-based combination of an organization. There are multiple projects going on at a time and each project has it’s team. However, the teams are made up of staff from different departments (R&D, regulatory, marketing, tech leads) who also are part of at least one other project for their respective role.…[Read more]

]]> 0 f835b9a4c0fc7f83990b2ada189a6a89 fo3 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/604/ Mon, 21 Nov 2016 01:37:48 -0500 In my opinion, I think a major mistake would be to assume that one is only looking for extreme and catastrophic risks and therefore overlooking risks that are also important. For example, there are risks due to safety that one may overlook and cause issues in the long run. There are business related risks that can be overlooked because one may be…[Read more]

]]> 0 cb6239c9b841792436bf6e8126e3497d fo3 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/603/ Mon, 21 Nov 2016 01:29:00 -0500 It is important to distinguish the types of risks you are analyzing. For example, there are risks that impact business, those that impact manufacturing, and the obvious risks with the device itself. A risk may be considered “high” level because it has a great impact on the business, but not necessarily manufacturing. The factors that determine…[Read more]

]]> 0 9b3012b99420fdcb1e038d6a94db1dbe fo3 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/600/ Mon, 21 Nov 2016 00:55:05 -0500 I agree – There comes a point where the company has done their part by putting warnings on labels and the customer who is using the device is responsible for following those instructions. For that to happen, it is expected that the user is trained to the proper handling and use prior to using it during surgery, for example. As many have said,…[Read more]

]]> 0 d97d1b10dbff7c6e3409bdaf7aba98b3 fo3 replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/379/ Sat, 12 Nov 2016 23:04:26 -0500 Deepthi, yes it is a common practice to keep these inputs and specs in an excel spreadsheet as part of the Design Requirements Matrix (DRM). This document may even be a live document that can only be seen by those on the design team and can be modified accordingly. In my recent experience, the DRM for a specific project has been posted on…[Read more]

]]> 0 0a4c50365eefbbca47ac84372729bf09 fo3 replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/377/ Sat, 12 Nov 2016 22:04:07 -0500 As we have learned and many have already mentioned, verification tests come about from the design specifications in the DSD. Each specification can have a test linked to it and will be explored during verification. However, not all specifications have to undergo design verification. Based on my experience, in the earlier stages, the quality…[Read more]

]]> 0 ba6dc3ed0d89680bb97f4e8d715642d0 fo3 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/376/ Sat, 12 Nov 2016 21:42:44 -0500 I’ve realized several things about Gantt charts in the industry. The plan laid out by Gantt chart should be followed as close as possible, especially since projects have deadlines to be met. However, one has to consider there will be setbacks and there will always be problems that cause dates to be pushed back or become more flexible. In my…[Read more]

]]> 0 bc0d2fe4bd82af97a3f15918b3a0772c fo3 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/169/ Sat, 05 Nov 2016 19:00:35 -0400 There are major differences between design verification and design validation. For one thing, validation always occurs after verification, and in some case may not be required at all. Verification tests the specifications of the device separately, while the validation stage tests the device as a whole to see if it meets user needs. Each design…[Read more]

]]> 0 8d775451edf7e3164ad5d831907e1c75 fo3 replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/166/ Sat, 05 Nov 2016 18:00:26 -0400 When developing an inputs document for a new product it may be a challenge to obtain or come up with the inputs and specifications. As mentioned in the lecture, R&D engineers may help support this by performing development tests or engineering studies. By experimenting, an engineer can come up with specs for mechanical inputs, such as torque,…[Read more]

]]> 0 6b3f9ef6849ab491b3506a8db9a26a31 fo3 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/122/ Thu, 03 Nov 2016 19:36:10 -0400 I agree that there exists an advantage to have the entire design process documented in a DHF versus a snapshot of the design process with the Design Dossier or Tech File. For one thing, we are able to see every aspect of the product from start to finish. It is the proof that the product was designed to be safe, meets user needs and requirements,…[Read more]

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