Medical Device Courses | Chris Vasquez | Activity https://medicaldevicecourses.com/members/chrisvasquez/activity/ Activity feed for Chris Vasquez. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 3f371475306015d9a3ff4a421d254230 Chris Vasquez replied to the topic "Consent and predicted outcome" - https://medicaldevicecourses.com/activity/p/12583/ Wed, 15 May 2019 16:57:19 -0400 It’s really hard to have a animal study fully represent the potential effects of a drug/medical device within a human. There are so many variables within a human that can drastically effect how the drug/medical device will respond or more…   Read more»

]]> 27d77e12338691f19ab1edc409474c1f Chris Vasquez replied to the topic "AMDD" - https://medicaldevicecourses.com/activity/p/12582/ Wed, 15 May 2019 16:57:19 -0400 As someone who is starting there career within the medical device industry and applying what was learned in class, I felt that applying my knowledge from class concurrently with the application aspect helps me to fully understand what goes on…   Read more»

]]> c19ba999d378bc507827d6ccc47a98b1 Chris Vasquez replied to the topic "Simulation Experience" - https://medicaldevicecourses.com/activity/p/12580/ Wed, 15 May 2019 16:57:18 -0400 As someone who has worked within the medical device industry and consumer, these simulation have reminded me of the type of typical day to day problems/issues that could potentially occur. Their could be multiple approaches to solve these simulations, which…   Read more»

]]> 6d3971dbda306bd0ab7e04efd1369c17 Chris Vasquez replied to the topic "Disconnect in rewarding motivation" - https://medicaldevicecourses.com/activity/p/12578/ Wed, 15 May 2019 16:57:17 -0400 I have seen it myself sometimes the area disconnect, when I worked in consumer, I saw the constant push on the release of product from upper management, but never the recognition of a great job. I have seen that contracts…   Read more»

]]> 321d10d025a72915c80449869dda4f8f Chris Vasquez replied to the topic "Engineer vs. Manager" - https://medicaldevicecourses.com/activity/p/12576/ Wed, 15 May 2019 16:57:16 -0400 Great question, but I am quite sure where ideally I would like to end up. Ideally, I would like to work as an engineer for a few years… gain experience within the field and develop my career. Ideally after maximizing…   Read more»

]]> 72d9d44737228d9b71dfd2518a5bd478 Chris Vasquez replied to the topic "Why do people leave work?" - https://medicaldevicecourses.com/activity/p/12572/ Wed, 15 May 2019 16:57:14 -0400 I know a few people that had a fear of feeling ” too comfortable” at work, sometimes you adjust to a certain rhythym and just conform, as a result they move around to another position. Currently, I am transitioning from…   Read more»

]]> 711fcb790ea81a9f993de5f5c6ab74fe Chris Vasquez replied to the topic "career path" - https://medicaldevicecourses.com/activity/p/12514/ Wed, 15 May 2019 16:56:40 -0400 I would really enjoy going into R&D, but not within the clinical research area. I feel that this aspect within industry is probably one of the toughest. I attached a link to a website that talks about the pros and…   Read more»

]]> d7c3dcd29cc1d365f45378125a12d75e Chris Vasquez replied to the topic "Unexpected Clinical Study Results" - https://medicaldevicecourses.com/activity/p/12513/ Wed, 15 May 2019 16:56:40 -0400 Well in my opinion it depends, whether its as a result of the trial itself or the manufacturer of the drug. As the comments mentioned above, there could be an investigation on the drug, which find components to be not…   Read more»

]]> 1ceac68af0ddc57442f2af9f58cd3055 Chris Vasquez replied to the topic "Clinical Study Location/cost vs. results" - https://medicaldevicecourses.com/activity/p/12511/ Wed, 15 May 2019 16:56:39 -0400 Great topic, and I read an article with regards to shifting clinicial trials to third world countries because of the cost and the not as stringent regulations in other countries.
http://theconversation.com/ethics-vs-economics-the-cost-of-outsourcing-clinical-trials-to-developing-countries-43246

]]> b11b34a7ad2492d734dcb795e18fe8c3 Chris Vasquez replied to the topic "What’s Your Motivator?" - https://medicaldevicecourses.com/activity/p/12495/ Wed, 15 May 2019 16:56:32 -0400 My biggest motivation at work is the impact that the product that I work see manufacture has on the patients. In addition, my ambitions come from my family and friends that inspire me to go a step further than what…   Read more»

]]> 47be16c0779d4b4297477242354a53f7 Chris Vasquez replied to the topic "Let's Be Motivated!!!" - https://medicaldevicecourses.com/activity/p/12493/ Wed, 15 May 2019 16:56:31 -0400 The best method to motivate my team members, if i was a project manager, would be to show the influence the product being produced has on the users. For example, show the logistics on how the product is growing and…   Read more»

]]> 8201dd8af0027260cb9dba39eaf778ea Chris Vasquez replied to the topic "Why do people work?" - https://medicaldevicecourses.com/activity/p/12491/ Wed, 15 May 2019 16:56:30 -0400 As someone who works within the medical device industry, I am kind of surprised how “meaningful work/ make a difference” is listed so low. I know the engineers that I have spoken mostly stated that they want to make a…   Read more»

]]> b81e29efdbcca9287f5b3bc7155046b0 Chris Vasquez replied to the topic "Procurement Management" - https://medicaldevicecourses.com/activity/p/12426/ Wed, 15 May 2019 16:55:53 -0400 I don’t have direct experience within procurement, but I know that procurement is very contract oriented and once these suppliers are approved into the company, the company essentially has rights to be purchased from the company. In addition, approved vendor…   Read more»

]]> 679278fd728caf4eebc769d4c2f059cb Chris Vasquez replied to the topic "Integration PM" - https://medicaldevicecourses.com/activity/p/12413/ Wed, 15 May 2019 16:55:47 -0400 During summer internship, my main task was to reform out of a particular raw material. My internship consisted of several parts, which also incorporated a potential introduction to a new process change, if given enough time to complete the reform….   Read more»

]]> 49a847bad4e729639ce6bd392391843e Chris Vasquez replied to the topic "Organizational structure" - https://medicaldevicecourses.com/activity/p/12410/ Wed, 15 May 2019 16:55:45 -0400 From my experience, I am split between two departments, but I directly report to one. When the department that I am hired doesn’t have a major project in the works, I am sent to the quality department to help them…   Read more»

]]> 98255e7b221d0f18e12e1f8e8e29ef2f Chris Vasquez replied to the topic "correction vs corrective action" - https://medicaldevicecourses.com/activity/p/12388/ Wed, 15 May 2019 16:55:32 -0400 As Viraj mentioned, the CAPA itself is used to find the route cause of non-conformity and a method to address the NC, while creating a way to prevent it from happening again. During the CAPA execution, documentation may change such…   Read more»

]]> ec3d0a9beaf80ef7b1e8e7f7172dfb1f Chris Vasquez replied to the topic "Audits" - https://medicaldevicecourses.com/activity/p/12386/ Wed, 15 May 2019 16:55:31 -0400 We are actually doing an internal Audit either next week or the following. The biggest advantage about the internal audit is that potential issues can be addressed early before the outside auditor arrives. A corrective action can be initiated to…   Read more»

]]> b6da37efe031df4cb68eece1d2c073bb Chris Vasquez replied to the topic "Non-Conformity" - https://medicaldevicecourses.com/activity/p/12384/ Wed, 15 May 2019 16:55:30 -0400 I have personally dealt with a non-conformity, on a material that we manufacture, the material failed one of the critical inspection areas within Quality assurance, which opened an investigation to find the route cause of what caused the failure within…   Read more»

]]> d9e40332e184117be61c3a5c0ebdb0ad Chris Vasquez replied to the topic "Discussion Topic: Vagueness of GMP's" - https://medicaldevicecourses.com/activity/p/12326/ Wed, 15 May 2019 16:54:54 -0400 Ambiguity of GMPs for start up companies are completing understandable, I believe that is is a learning curve for these types of companies, because their product is being initialized in production and there are no pre-existing GMPs nor standards. As…   Read more»

]]> 447e43d54edabaf27ac24f1ec3710698 Chris Vasquez replied to the topic "No GMPs" - https://medicaldevicecourses.com/activity/p/12323/ Wed, 15 May 2019 16:54:52 -0400 In a No GMP aspect, I use to work for a company that did not utilize GMPs, and the process to upscale a potential product from lab to production became difficult at times, because methods that could replicate the lab…   Read more»

]]> 809b9b9a1935477144a9564d80e98921 Chris Vasquez replied to the topic "Improving GMPs" - https://medicaldevicecourses.com/activity/p/12322/ Wed, 15 May 2019 16:54:52 -0400 As technology improved, so has the ability to manufacture goods. I know from my experience, this improvement has constituted to an increase in areas of inspection or in other words inspection techniques have become more strict and controlled. All aspects…   Read more»

]]> bb51e7dd538d4ab779ad6e504f49b386 Chris Vasquez replied to the topic "FDA Recall...Now What?" - https://medicaldevicecourses.com/activity/p/12320/ Wed, 15 May 2019 16:54:51 -0400 Based on the provided information, I agree with the assessments above, I believe that a change order would be needed and this change should be addressed with R&D and Quality. In addition, a risk assessment on the device should be…   Read more»

]]> 48f9e734344b15bf3f127305bd7ab7fe Chris Vasquez replied to the topic "Design Review Meeting Culture" - https://medicaldevicecourses.com/activity/p/12319/ Wed, 15 May 2019 16:54:50 -0400 I have never personally done a design change from an initial design standpoint, but I have made Engineering Change Orders on documentations post the design change. Essentially these change orders have to be approved by R&D, Quality, and the effected…   Read more»

]]> 5bf960076a7e8db1c92f2dfbc20edff6 Chris Vasquez replied to the topic "Risk Management" - https://medicaldevicecourses.com/activity/p/12318/ Wed, 15 May 2019 16:54:49 -0400 An example of risk that I have personally worked with was the creating of SOP’s for in process checking, the SOP that was created ensured proper inspection of the manufactured product. We had to ensure that all operators were trained…   Read more»

]]> 54734a1e5e6111cea155a90bdf30f53f Chris Vasquez replied to the topic "Product Life Cycle Curve" - https://medicaldevicecourses.com/activity/p/12256/ Wed, 15 May 2019 16:54:14 -0400 In my opinion, I feel that Research and Development is probably your highest investment, you want to ensure that the product you are developing meets specific standards and criteria’s, a project after designed can undergo trials, where they fail or…   Read more»

]]> 007e03953038aef126b6ab00c5197ef3 Chris Vasquez replied to the topic "Product Failure" - https://medicaldevicecourses.com/activity/p/12255/ Wed, 15 May 2019 16:54:14 -0400 As you mentioned, recalls may be detrimental to the reputation of a company. Particularly the possibility of litigation. Below I attached a link to an article about a lawsuit that is currently happening with Merck.

http://www.investopedia.com/news/mercks-zostavax-drug-hit-lawsuits-mrk-gsk/

]]> 5a9c14a458810c5bab5ff55c750d7df9 Chris Vasquez replied to the topic "Interpersonal Skills" - https://medicaldevicecourses.com/activity/p/12254/ Wed, 15 May 2019 16:54:13 -0400 I completely agree, to be in business you have to have an the knowledge of industry and most importantly the ability to speak and negotiate with potential buyers. I know I personally deal with a particular vendor and he goes…   Read more»

]]> 4a52e72c7cc32e29b4b853cacc3eb829 Chris Vasquez replied to the topic "product manager role" - https://medicaldevicecourses.com/activity/p/12206/ Wed, 15 May 2019 16:53:47 -0400 I agree with the comments above, it is difficult to point at which role would be the most critical for a project manager. If I were to take a guess, I assume that creating the story behind the product line….   Read more»

]]> a6ef26f3329f8560dbe544c4b9897729 Chris Vasquez replied to the topic "Go or Kill" - https://medicaldevicecourses.com/activity/p/12204/ Wed, 15 May 2019 16:53:46 -0400 I have heard from fellow coworkers of projects being “killed” because of a shift within the market or money is shifted to another project due to unforseen circumstances. In this instance, the project is not fully killed but just put…   Read more»

]]> 528a0751cf6111f6b261bed20f91b2ad Chris Vasquez replied to the topic "Product Failure" - https://medicaldevicecourses.com/activity/p/12203/ Wed, 15 May 2019 16:53:45 -0400 I personally never had experience dealing with recalls, but I assume that are some costly side effects from a recalls such as tainting of the company brand to potential litigation if the recall is based on causing harm to individuals….   Read more»

]]> 221e8a1291c9309f84e786f6c6f892f6 Chris Vasquez replied to the topic "PM: Quality Assurance Process" - https://medicaldevicecourses.com/activity/p/12126/ Wed, 15 May 2019 16:53:00 -0400 From my experience the quality assurance team performs tests on everything that comes in for product to ensure that the material meets it’s specifications. They also test materials from vendors, and ensure that the vendor material meet our specifications. From…   Read more»

]]> 1f4b42d50118722f96716e78adf3e510 Chris Vasquez replied to the topic "PM: Handling Team Issues" - https://medicaldevicecourses.com/activity/p/12124/ Wed, 15 May 2019 16:52:59 -0400 As a PM, these types of scenarios should be anticipated with proper communication between all team members. As a result the project manager as the responsibility to organize and communicate between team members, it is important to have weekly updates…   Read more»

]]> 49d357bbe746c9ced820ada482de70cf Chris Vasquez replied to the topic "Source Selection in Executing Process" - https://medicaldevicecourses.com/activity/p/12123/ Wed, 15 May 2019 16:52:59 -0400 Ussually when looking at vendors the company has a list of approved suppliers that would ease the purchasing aspect because prior business has already been initiated,and buying from an approved supplier means that you know what type of quality of…   Read more»

]]> f65bb3145a98193c8f77d5aef6ee15cc Chris Vasquez replied to the topic "Maintenance & validation" - https://medicaldevicecourses.com/activity/p/12059/ Wed, 15 May 2019 16:52:26 -0400 Hi Fady, when we say severe failure, are there critical components within the equipment that broke down or is the product itself being produced or being check incorrectly? I would say that we should treat this as a preventative maintenance…   Read more»

]]> fa49526c30f79eec434589bc93245a34 Chris Vasquez replied to the topic "Simulation" - https://medicaldevicecourses.com/activity/p/12055/ Wed, 15 May 2019 16:52:25 -0400 Well it depends, setbacks and delays often occur, but my question is, since this component is critical, does Arugalo Medical have a list of approved suppliers for this component and is this company the only supplier? Lastly, wouldn’t it be…   Read more»

]]> bf7af1badc40db84ae800bb3be4ec812 Chris Vasquez replied to the topic "Validation Expiration" - https://medicaldevicecourses.com/activity/p/12053/ Wed, 15 May 2019 16:52:24 -0400 That a good question and it could be slightly trivial to answer. I believe that the original validation would not expire, but lets says there is a gap between the validation such as let’s say that you just did an…   Read more»

]]> 9041b9d992b18631894a2ff38269c378 Chris Vasquez replied to the topic "Are Missed Milestones really Bad?" - https://medicaldevicecourses.com/activity/p/12050/ Wed, 15 May 2019 16:52:22 -0400 I don’t think missing a major milestone can particular effect future success of a product/project, delays should be anticipated and addressed in a timely fashion. Usually project managers incorporate potential delays/setbacks within their timelines, because they do happen. Now is…   Read more»

]]> bd1018a614769ff0e5f6cfe649488f30 Chris Vasquez replied to the topic "Benefits of this course" - https://medicaldevicecourses.com/activity/p/12047/ Wed, 15 May 2019 16:52:21 -0400 I agree the comments above, with the support of Dr. Simon’s courses I feel that his courses provide a real world approach and look within industry. There have been countless of times were I refer back to my lecture notes…   Read more»

]]> aa110c634c8b7198bf6c411287fb4cab Chris Vasquez replied to the topic "PM Internationally" - https://medicaldevicecourses.com/activity/p/12045/ Wed, 15 May 2019 16:52:19 -0400 I agree with the comments above, I believe that the biggest difference would be dealing with the diverse regulations. From my previous experience within a cosmetic standpoint, I was working on a reform on an overseas product, both the overseas…   Read more»

]]> 1bb5b10a98e4a54780e8f0ad11982356 Chris Vasquez replied to the topic "Process Revalidation" - https://medicaldevicecourses.com/activity/p/11964/ Wed, 15 May 2019 16:51:30 -0400 I had a similar experience, but with the purchase of a 2 identical pieces of equipment, but they were being placed at two different locations. We had to validate each piece of equipment, but with regards to our Test method…   Read more»

]]> 1e6842b954750db55cc20f52a6d92057 Chris Vasquez replied to the topic "Types of Validation" - https://medicaldevicecourses.com/activity/p/11963/ Wed, 15 May 2019 16:51:29 -0400 Hi Viraj, it really depends on the equipment or the process you are trying to validate. There are some, for instance if you purchase equipment from a vendor, there are cases were you can validate this equipment as an COTS…   Read more»

]]> ae70add2ebe63f13d6f78da10db0a883 Chris Vasquez replied to the topic "Revising a Gantt Chart" - https://medicaldevicecourses.com/activity/p/11962/ Wed, 15 May 2019 16:51:29 -0400 Interesting topic, but is the balloon popping an isolated incident or does it happen all the time? I do agree that more time will be needed by R&D to address this issue, but is this product already in the market?…   Read more»

]]> f74b48ca1a19160c5631a299ee71e2cf Chris Vasquez replied to the topic "Missing a Milestone Experience" - https://medicaldevicecourses.com/activity/p/11961/ Wed, 15 May 2019 16:51:29 -0400 For my senior design project, we were working on a non-invasive vascular stiffness monitor, we were prototyping on bread board, which connected to a an ossciliscope for data analysis. Half way through our project we realized that the breadboard had…   Read more»

]]> d205399936262b114724aba699b9f78d Chris Vasquez replied to the topic "Underestimating Task Duration" - https://medicaldevicecourses.com/activity/p/11959/ Wed, 15 May 2019 16:51:28 -0400 I have had a a few experiences in which completion of projects have been delayed, I was validated a new piece of lab equipment, during the validation process i ran into delays ranging from the acquisition of testing equipment to…   Read more»

]]> 0f9d77a3984acbbd48f1821703aa7330 Chris Vasquez replied to the topic "Discussion Topic: ECO's" - https://medicaldevicecourses.com/activity/p/11912/ Wed, 15 May 2019 16:50:58 -0400 I would say that it depends on the severity of the change, if its a major change that all documents should be adjusted and perhaps another safety assessment may be needed if it changes the function of the device. If…   Read more»

]]> 4895f4f580a85099419977a23a19dd57 Chris Vasquez replied to the topic "DHF vs. DHR" - https://medicaldevicecourses.com/activity/p/11911/ Wed, 15 May 2019 16:50:57 -0400 The essential differences are is that DMR contains all documentation for the design and manufacturing of the current product and all process are fully documented, while DHR contains all production/process records of the device.

Chris

]]> e5c8c3dcab6c240e745aff915fa4c89e Chris Vasquez replied to the topic "Discussion Topic: Post-market surveillance" - https://medicaldevicecourses.com/activity/p/11910/ Wed, 15 May 2019 16:50:57 -0400 From my experience the tracking of medical devices in the post market surveliance often comes consumer feedback itself, we have a team that dedicates themselves to addressing potential issues. The address concerns with the use of the device and often…   Read more»

]]> 0d5e27d1f8ddb8f46ce93d80577580b1 Chris Vasquez replied to the topic "Discussion Topic: The critical path" - https://medicaldevicecourses.com/activity/p/11894/ Wed, 15 May 2019 16:50:48 -0400 I had that happen to me when I was working in the consumer sector, I was reforming out of a ester that is now discontinued, it was believed that it was going to be a very simple reform of a…   Read more»

]]> dd8807ce8a6b7595d1a6208351ef3306 Chris Vasquez replied to the topic "Discussion Topic: The proper time for Project Initiation" - https://medicaldevicecourses.com/activity/p/11891/ Wed, 15 May 2019 16:50:46 -0400 Based on the information give, since the material has been in the development phase for a decade, the potential of the material should by now be known or at least have a pretty good idea on what it could do…   Read more»

]]> 061a1a1379ede2b4b479b03b06001bc5 Chris Vasquez replied to the topic "how the PM handles budget cut?" - https://medicaldevicecourses.com/activity/p/11889/ Wed, 15 May 2019 16:50:44 -0400 Hi All, I can definitely agree that a budget cut will effect the project, thus area that may have been clear may have to be reanalyze to take into consideration the budget limitation. This aspect is very important for the…   Read more»

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