Medical Device Courses | rab38 | Activity https://medicaldevicecourses.com/members/rab38/activity/ Activity feed for rab38. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e7d233bfb1db646a1b3da674a018ef6b rab38 replied to the topic "Tests for validation and verification phase" - https://medicaldevicecourses.com/activity/p/11701/ Wed, 15 May 2019 16:48:51 -0400 There are typically pre-existing standards for the verification testing. International ISO standards exist to insure that proper function and safety are accomplished. Additionally, for medical devices, FDA regulations define verification and validation in design control training. Proper traceability and documentation…   Read more»

]]> aa47aeae02f7f874b8f9b11fd5383549 rab38 replied to the topic "Experience with Design Control" - https://medicaldevicecourses.com/activity/p/11699/ Wed, 15 May 2019 16:48:50 -0400 I am also currently doing my senior design project as well. It is clear to see that it simulates the design control process. I would like to add that we have a design review coming up to go over the…   Read more»

]]> bbcc4f50cc86905bf871d41818244398 rab38 replied to the topic "Product Life Cycle" - https://medicaldevicecourses.com/activity/p/11696/ Wed, 15 May 2019 16:48:48 -0400 That is true Roberto. It definitely depends on the product, but I agree that they will all go through the life-cycle. This however can extend over various durations as the product may be difficult to replace or not as susceptible…   Read more»

]]> 16abb8fa1aec34b3eb33db32d9e9a6da rab38 replied to the topic "Human Factors study in combination products" - https://medicaldevicecourses.com/activity/p/11595/ Wed, 15 May 2019 16:47:57 -0400 You bring up an important point krp76. Both the instructions and training play a pivotal role in ensuring that Human Factor aspect is well considered. Taking into consideration all aspects at play is important in addressing any issues of miscommunication….   Read more»

]]> dee0aa52b22f43e2ec109e13747fe148 rab38 replied to the topic "Significant or non-significant risk" - https://medicaldevicecourses.com/activity/p/11594/ Wed, 15 May 2019 16:47:57 -0400 From the information I found a significant risk device is one that can present a possibility to affect the health, safety or well-being of an individual. These are often class II or III devices such as sutures, pacemakers and various…   Read more»

]]> e8378b9351220e2ee4e52d2011fc12ad rab38 replied to the topic "Difference" - https://medicaldevicecourses.com/activity/p/11592/ Wed, 15 May 2019 16:47:56 -0400 Hello, There are great points made above. I agree with the aspect of their similarity in terms of being responsible for the completion of projects in a timely manner. Organizing individuals, delegating responsibilities and coordinating schedules. However, as mentioned by…   Read more»

]]> 96a0808301aef7eedc5eba413bbc7845 rab38 replied to the topic "Project Manager Skills" - https://medicaldevicecourses.com/activity/p/11498/ Wed, 15 May 2019 16:45:28 -0400 You bring up a great point Roberto. I would like to add that though many of those in the project management role are good communicators, there is an additional skill that only some have. This skill is being able to…   Read more»

]]> 0f86ceb8805160eee995dd2738a37e96 rab38 replied to the topic "Discussion Topic: Projects of all types" - https://medicaldevicecourses.com/activity/p/11497/ Wed, 15 May 2019 16:45:27 -0400 I believe a majority of project management skills are applicable across the multiple disciplinary fields. These include effective communication, leadership, team management and organizational skills. These skills can be effective regardless of the industry. However, to be an effective project…   Read more»

]]> 00eeb511e23fb1a2cf068b0803e2e5ff rab38 replied to the topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/11496/ Wed, 15 May 2019 16:45:27 -0400 From my time at Maquet I got the opportunity to work on multiple projects. Though departments were typically split functionally, a majority of the time an individual was assigned to each project. However, based on time constraints and the work…   Read more»

]]> e73abeee92c295ddda0b57cce18e6ea8 rab38 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11424/ Wed, 15 May 2019 16:44:51 -0400 You make a great point Juan. Anything valuable in terms of an agreement should be appropriately recorded. Especially in business when valuable ideas, ventures and careers are at stake. Though, as a few of our classmates mentioned, an oral agreement…   Read more»

]]> a16b5cbf17406e05c7b91a126364289e rab38 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11423/ Wed, 15 May 2019 16:44:50 -0400 I would like to suggest “Medical Device Industry Preparedness” or something similar in terms of preparation for work across a variety of disciplines in the Medical Device or even a more broad Medical and Pharmaceutical Industry. I believe that this…   Read more»

]]> abab2a4f982f15dde3c811a54682da83 rab38 replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/11422/ Wed, 15 May 2019 16:44:50 -0400 Hello, I feel our class mates described the difference very well. I would just like to add that at times the idea may not be developed enough to allow for a patent application. In these cases it is advised to…   Read more»

]]> 3956672f326159199fea70b888157c5c rab38 replied to the topic "Organization Type vs. Effectiveness" - https://medicaldevicecourses.com/activity/p/11290/ Wed, 15 May 2019 16:43:39 -0400 Hi Saad, I agree with your point. However, I think it is more than just the size of the company that decides the best organizational structure. I believe it could vary based on the type of company, individuals involved and…   Read more»

]]> 8f6f898f7c68ecdda2bfc69e1a219021 rab38 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11287/ Wed, 15 May 2019 16:43:38 -0400 I work in a similar environment. I certainly agree that the convenience of have an entire, or a majority, of the department be familiar with the ongoing projects means that if an individual is unavailable you can seek help from…   Read more»

]]> 720cc11af980a00c2c744a43dcc74729 rab38 replied to the topic "Project Management Preferences" - https://medicaldevicecourses.com/activity/p/11284/ Wed, 15 May 2019 16:43:36 -0400 Luisa, You make a great point. In addition I would like to point out that in a matrix organization each staff member has at least 2 bosses, as mentioned in Dr. Simon’s lecture. I believe this can add to the…   Read more»

]]> c20102eb682a97300ac25958bf88a3bc rab38 replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/11104/ Wed, 15 May 2019 16:39:56 -0400 Hello, The term ‘As Far As Possible’ certainly could pose a difficult situation. However, I believe that there should be no possible risk left unconsidered, even if it is extremely unlikely. The intentions of a medical device is to be…   Read more»

]]> f31afdaaf65f59fc0ec17bd57933803f rab38 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10888/ Wed, 15 May 2019 16:37:34 -0400 Hello, Though I agree with your thought that a Gantt Chart is important, there is much more that goes into the scheduling process. It is extremely important to keep up with this schedule as it should be a living one…   Read more»

]]> 7ff1c70cfd9d90e21d73e3fb6aa872d5 rab38 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10885/ Wed, 15 May 2019 16:37:33 -0400 Hello, I believe there are many aspects that are required for design input. The first is user needs, or what the consumer is looking for in the product. These needs can then be used to devise design concepts and weigh…   Read more»

]]> e8072b8789d2a4e768f869c2226da881 rab38 replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/10883/ Wed, 15 May 2019 16:37:31 -0400 Hey Saad, You bring up a great point! Inefficiency and wasting time is extremely costly to the device development process. Issues such as unclear requirements may lead to an insufficient design control and review. When the objectives of the device…   Read more»

]]> ea8828be25fc428cf595ea49fe9fa272 rab38 replied to the topic Tests for validation and verification phase in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1358/ Sun, 05 Feb 2017 22:19:30 -0500 There are typically pre-existing standards for the verification testing. International ISO standards exist to insure that proper function and safety are accomplished. Additionally, for medical devices, FDA regulations define verification and validation in design control training. Proper traceability and documentation must also exist to adequately…[Read more]

]]> 0 ac0c216a33dff8ccbbcdd4e3305d080f rab38 replied to the topic Experience with Design Control in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1356/ Sun, 05 Feb 2017 22:03:52 -0500 I am also currently doing my senior design project as well. It is clear to see that it simulates the design control process. I would like to add that we have a design review coming up to go over the project design requirements. I believe this will give us a better understanding of the process. Learning about it beforehand in this course will only…[Read more]

]]> 0 e01355344f4703cc1ef38f043a443182 rab38 replied to the topic Product Life Cycle in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1353/ Sun, 05 Feb 2017 21:43:21 -0500 That is true Roberto. It definitely depends on the product, but I agree that they will all go through the life-cycle. This however can extend over various durations as the product may be difficult to replace or not as susceptible to technological advancements.An example of this is adhesive bandages, band-aids. Though fabrics, adhesives and other…[Read more]

]]> 0 78e63ae9eb26a9e198318c1a8e0d0781 rab38 replied to the topic Human Factors study in combination products in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1201/ Sat, 28 Jan 2017 21:30:37 -0500 You bring up an important point krp76. Both the instructions and training play a pivotal role in ensuring that Human Factor aspect is well considered. Taking into consideration all aspects at play is important in addressing any issues of miscommunication. Well written instructions as mentioned are a great start, but proper labeling also plays a…[Read more]

]]> 0 ad91d3b488fbb49625aab320d1b172ef rab38 replied to the topic Significant or non-significant risk in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1200/ Sat, 28 Jan 2017 21:13:18 -0500 From the information I found a significant risk device is one that can present a possibility to affect the health, safety or well-being of an individual. These are often class II or III devices such as sutures, pacemakers and various implants. Non-Significant risk devices, however, do not have the possibility of causing a life- threatening risk to…[Read more]

]]> 0 efe2c0e638f0e68a748630abd9c55575 rab38 replied to the topic Difference in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1198/ Sat, 28 Jan 2017 20:50:35 -0500 Hello,

There are great points made above. I agree with the aspect of their similarity in terms of being responsible for the completion of projects in a timely manner. Organizing individuals, delegating responsibilities and coordinating schedules. However, as mentioned by our classmates, the term project manager can apply to a wide variety of…[Read more]

]]> 0 add299972504ddb36e4a5f2d5fef4eda rab38 replied to the topic Project Manager Skills in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1048/ Sun, 22 Jan 2017 02:52:54 -0500 You bring up a great point Roberto. I would like to add that though many of those in the project management role are good communicators, there is an additional skill that only some have. This skill is being able to effectively communicate and this involves knowing your employees and coworkers. I believe this quality truly allows for excellent PMs…[Read more]

]]> 0 ab80c8ce097309cb33fd81effa375178 rab38 replied to the topic Discussion Topic: Projects of all types in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1047/ Sun, 22 Jan 2017 01:41:00 -0500 I believe a majority of project management skills are applicable across the multiple disciplinary fields. These include effective communication, leadership, team management and organizational skills. These skills can be effective regardless of the industry. However, to be an effective project manager, I believe a certain level of knowledge in the…[Read more]

]]> 0 81b4bab0563e796d44895ba6018770ce rab38 replied to the topic Discussion Topic: State of your Organization in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1046/ Sun, 22 Jan 2017 01:00:15 -0500 From my time at Maquet I got the opportunity to work on multiple projects. Though departments were typically split functionally, a majority of the time an individual was assigned to each project. However, based on time constraints and the work necessary others in the department would also get involved. This system was usually effective, but often…[Read more]

]]> 0 b39ba2466d9d7e6778c90b4db4a6ffff rab38 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/925/ Mon, 05 Dec 2016 03:35:01 -0500 You make a great point Juan. Anything valuable in terms of an agreement should be appropriately recorded. Especially in business when valuable ideas, ventures and careers are at stake. Though, as a few of our classmates mentioned, an oral agreement can be validated, it is much more difficult and requires more defined evidence to rule one way or…[Read more]

]]> 0 62ffc337cb9dbdddafe90f563fce105a rab38 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/924/ Mon, 05 Dec 2016 03:17:23 -0500 I would like to suggest “Medical Device Industry Preparedness” or something similar in terms of preparation for work across a variety of disciplines in the Medical Device or even a more broad Medical and Pharmaceutical Industry. I believe that this class has definitely delivered a much deeper look into the responsibilities of different…[Read more]

]]> 0 9829fa6082cd0cecb8410afe98b0967b rab38 replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/923/ Mon, 05 Dec 2016 03:07:08 -0500 Hello,

I feel our class mates described the difference very well. I would just like to add that at times the idea may not be developed enough to allow for a patent application. In these cases it is advised to have an NDA and apply for a provisional patent, which is a legal document filed before the developed patent to ensure an early filing date…[Read more]

]]> 0 2c3f511a923e992ed729d01a96e9b379 rab38 replied to the topic Organization Type vs. Effectiveness in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/761/ Mon, 28 Nov 2016 01:12:11 -0500 Hi Saad,

I agree with your point. However, I think it is more than just the size of the company that decides the best organizational structure. I believe it could vary based on the type of company, individuals involved and even the project itself. This being said, it may be impractical to vary the organizational structure with each product. I…[Read more]

]]> 0 d3eb9f9dc7b64f3d8a0c9e7e236cc1b1 rab38 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/758/ Mon, 28 Nov 2016 00:41:51 -0500 I work in a similar environment. I certainly agree that the convenience of have an entire, or a majority, of the department be familiar with the ongoing projects means that if an individual is unavailable you can seek help from another in the department. I found this especially helpful in the case of documentation control department. Many of the…[Read more]

]]> 0 ef4f3d164ac5b2d28974979aad00e638 rab38 replied to the topic Project Management Preferences in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/755/ Mon, 28 Nov 2016 00:32:39 -0500 Luisa,

You make a great point. In addition I would like to point out that in a matrix organization each staff member has at least 2 bosses, as mentioned in Dr. Simon’s lecture. I believe this can add to the difficulty of carrying out this organizational style as there may be cases where they have conflicting opinions. This can lead to delays,…[Read more]

]]> 0 a0292279a824745ab960e311bc2e4bc4 rab38 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/524/ Fri, 18 Nov 2016 00:53:11 -0500 Hello,

The term ‘As Far As Possible’ certainly could pose a difficult situation. However, I believe that there should be no possible risk left unconsidered, even if it is extremely unlikely. The intentions of a medical device is to be safe and effective. With safety being of utmost importance. This is a responsibility that falls on the risk…[Read more]

]]> 0 e4b951b86ebce3eee35c81e9d18c56be rab38 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/236/ Mon, 07 Nov 2016 02:04:56 -0500 Hello,

Though I agree with your thought that a Gantt Chart is important, there is much more that goes into the scheduling process. It is extremely important to keep up with this schedule as it should be a living one that is constantly updated based on the progress made. Other aspects that play into the schedule may also include milestones that…[Read more]

]]> 0 bee6ddc3dc8d5bcd5f843d41a8f36563 rab38 replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/232/ Mon, 07 Nov 2016 01:47:30 -0500 Hello,

I believe there are many aspects that are required for design input. The first is user needs, or what the consumer is looking for in the product. These needs can then be used to devise design concepts and weigh them to find the final concept. This concept can then be used and translated into engineering requirements specifying device…[Read more]

]]> 0 71c4c082603c3306d81a968c854f5dc8 rab38 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/230/ Mon, 07 Nov 2016 01:38:40 -0500 Hey Saad,

You bring up a great point! Inefficiency and wasting time is extremely costly to the device development process. Issues such as unclear requirements may lead to an insufficient design control and review. When the objectives of the device are unclear it is difficult to give accurate feedback. To avoid this issue clear cut requirements…[Read more]

]]> 0