Medical Device Courses | es338 | Activity https://medicaldevicecourses.com/members/es338/activity/ Activity feed for es338. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 dfd92e7c0c3e3e9837641652b6e65d09 es338 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/17412/ Wed, 15 May 2019 21:39:15 -0400 Dr. Simon, I appreciate the material that you are teaching in this class as it is extremely applicable to the industry. This course has allowed be to expand my knowledge in my current position and has allowed me to use…   Read more»

]]> 0cc886f45543cbc022964f371c0e4004 es338 replied to the topic "Anti-kickback & Stark Cases" - https://medicaldevicecourses.com/activity/p/17406/ Wed, 15 May 2019 21:39:12 -0400 False Claims Act violations can result in the following: • Damages penalty triples the amount of money defrauded from the government • Claim penalties from $11,000 – $22,000 for each claim that violates the False Claims Act Anti-kickback Status (AKS)…   Read more»

]]> 994b2706192d8f9b602ef3a2f3401489 es338 replied to the topic "Your Organizational prference; but why?" - https://medicaldevicecourses.com/activity/p/17290/ Wed, 15 May 2019 21:38:16 -0400 Currently, I work in a Matrix Organization which is project-based, where there is a representative per functional group that is responsible for successfully moving the project through the developmental phases and creating the documents required for the DHF. Each project…   Read more»

]]> bb5ef973174045f8dd56d5d4e551ba17 es338 replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/17217/ Wed, 15 May 2019 21:37:37 -0400 I am surprised to hear as well that instructions for use (IFU) and labels are deemed as the least effective way to solve residual risk since the amount of effort that is taken to ensure the content on the packaging…   Read more»

]]> 489f20cc0cd8c5670e000ae7c279212a es338 replied to the topic "Sample Size Based on Risk Analysis" - https://medicaldevicecourses.com/activity/p/17214/ Wed, 15 May 2019 21:37:35 -0400 As hc225 mentioned, from experience in the industry, AQL levels are in place for the critical dimensions from the technical drawings of the product. Quality Control (QC) measures are conducted for every batch of product. As I have experienced with…   Read more»

]]> 856d1e1ba0a51cb0adb9aad230f097a3 es338 replied to the topic "Auditor's view of DHF / DHR" - https://medicaldevicecourses.com/activity/p/17112/ Wed, 15 May 2019 21:36:45 -0400 Hello, I have recently participated in a Medical Device Single Audit Program (MDSAP) audit and am currently preparing for the second part of the same audit within the end of this year. MDSAP is a single audit for medical devices…   Read more»

]]> becf927a5861685cbc67dc40c2c9c83c es338 replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/17109/ Wed, 15 May 2019 21:36:43 -0400 Hello, General consequences of insufficient design controls: • Design not meeting the needs or wants of the intended market/customer • Faulty product in the market requiring replacements • Product having a negative ROI • Product success = company reputation; potentially…   Read more»

]]> b373140a2789d082357e6cae02f850d4 es338 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/17108/ Wed, 15 May 2019 21:36:42 -0400 Hello, I have some experience developing Gantt charts through my undergraduate program and through industrial experience. From my perspective, some important factors before starting the Gantt chart are as follows: • Define generic key milestones of the project • Identify…   Read more»

]]> e60c92af43d3185fc571d1221a3ff705 es338 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/17007/ Wed, 15 May 2019 21:35:52 -0400 As a Project Coordinator who takes the meeting minutes from each meeting, I agree with Dr. Simon’s push on the importance of taking meeting minutes. Meeting minutes captures the discussions of the meetings with the program team – allowing those…   Read more»

]]> d3b66fbdc0f5ca74170bc87573ac729c es338 replied to the topic "Deviations That Occurs During Verification" - https://medicaldevicecourses.com/activity/p/17006/ Wed, 15 May 2019 21:35:52 -0400 Through my experience working as a Project Coordinator in the medical industry, I have encountered a two verification tests that didn’t meet the design requirements that were in place for that product. We were verifying a modification of an existing…   Read more»

]]> d06a4dea12555ccbf96647667d359517 es338 replied to the topic "Clinical Trial Roles" - https://medicaldevicecourses.com/activity/p/16913/ Wed, 15 May 2019 21:35:03 -0400 Guidance for Clinical Trial Sponsors: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf I would select to be a sponsor for clinical research because they are responsible for initiating the clinical investigation, documenting the research, and submitting the IDE with Regulatory. Sponsors are Medical/Clinical subject matter…[Read more]

]]> ebae1eae649a1a9a3030c8696d399b9d es338 replied to the topic "Brand Coloring" - https://medicaldevicecourses.com/activity/p/16800/ Wed, 15 May 2019 19:42:46 -0400 Marketing research indicates that approximately 80% of visual information is based on color and a person can only keep 3-4 pieces of information stored in short term memory at one time. A lot of time, money, and effort is placed…   Read more»

]]> 13bc322a6b6ae6201dbf3ba6750c0de2 es338 replied to the topic "Fuzz before launch of product." - https://medicaldevicecourses.com/activity/p/16796/ Wed, 15 May 2019 19:42:44 -0400 From experience in the industry, the company’s Marketing lead for that project will reach out to their sales team in each region or country and have initial discussions to understand the markets needs, wants, and anticipated interest in the product…   Read more»

]]> d64852fd98b7c6744e4d577b83bb6ad7 es338 replied to the topic "WHAT IS MARKETING TO YOU?" - https://medicaldevicecourses.com/activity/p/16792/ Wed, 15 May 2019 19:42:40 -0400 Marketing is having the ability to understand the customer’s needs and wants and utilizing those specific tenders into design inputs and marketing outputs. Sales is understanding the design outputs and communicating them as benefits that will meet the customers’ needs…   Read more»

]]> e81685ee2e1fa02acaabbc25c098c8dd es338 replied to the topic "Public vs. Private Companies" - https://medicaldevicecourses.com/activity/p/16704/ Wed, 15 May 2019 19:41:47 -0400 Private companies, in my opinion, have more of a small business feel even though they can be very large in size. They have a small number of owners, they are not traded publicly, yet the shares are amongst its employees….   Read more»

]]> 4282f457ad48831931a90476012dd3bb es338 replied to the topic "Discussion Topic: Inc. vs. LLC in the US" - https://medicaldevicecourses.com/activity/p/16700/ Wed, 15 May 2019 19:41:44 -0400 I think when a company is selecting between corporation (Inc) or limited liability company (LLC), it needs to weigh the pros and cons against the company’s overall mission. If a mid-size company with 50 people and $10 million in revenue…   Read more»

]]> 1724de69448ab6eac229cf93c44e3d9c es338 replied to the topic "Form 483" - https://medicaldevicecourses.com/activity/p/16545/ Wed, 15 May 2019 19:40:11 -0400 The company’s SOPs in Quality Control (QC) should ensure meeting all regulatory requirements for their medical products, and should include preventative actions to ensure avoidance of receiving a Form 483. An assumption of mine would be perhaps the company is…   Read more»

]]> 820a5833a894f5b1c3c75964023b972f es338 replied to the topic "What are some ways Document Control can improve?" - https://medicaldevicecourses.com/activity/p/16543/ Wed, 15 May 2019 19:40:10 -0400 I definitely agree with your response alexandrabuga. From a global standpoint, both 21 CFR 820 and ISO 13485 are guidelines for medical device companies to use for not only documenting, but ensuring procedures for controlling quality are in place and…   Read more»

]]> 2079a5e2837e9fd8e092133616a581c2 es338 replied to the topic "How Quality Departments React to Audits" - https://medicaldevicecourses.com/activity/p/16541/ Wed, 15 May 2019 19:40:09 -0400 I have participated in 1 unannounced FDA audit and 1 MDSAP mock audit in the medical industry before. Prior to each audit, there are a series of training sessions for audit preparation that is mandatory for those who will be…   Read more»

]]> 1d44b092020f8075e66d47b3444c50fd es338 replied to the topic "PM in Pre-Clinical/Clinical Studies" - https://medicaldevicecourses.com/activity/p/16343/ Wed, 15 May 2019 19:38:20 -0400 Like any other project, the Project Manager is fully involved in pre-clinical studies. PMs are involved in the preparation of the business case and need for the study, developing the schedule, budget, and coordinating the team through each stage (planning,…   Read more»

]]> ce6fcc0f910f5b358ee90de9ee861eda es338 replied to the topic "Ethics of Animal Testing" - https://medicaldevicecourses.com/activity/p/16341/ Wed, 15 May 2019 19:38:19 -0400 This is a very difficult topic because it is an opinionated debate between necessity versus ethics. And it appears from the majority of the feedback from our classmates, animal testing is bottom line unethical, but is necessary to an extent…   Read more»

]]> 9e036b43f1f74096de0696ca55e5ef44 es338 replied to the topic "Thoughts on BS, MS, and PhD in BME" - https://medicaldevicecourses.com/activity/p/16159/ Wed, 15 May 2019 19:17:46 -0400 Great topic!! I wish there were more responses because I am too (not to sound repetitive) very curious about this. I have been torn with the decision of MS versus PhD. I currently am working towards an MS and work…   Read more»

]]> 3559a6236a659c76d1d37bf0bd8b8a7e es338 replied to the topic "Advice for Biomedical Engineering Students" - https://medicaldevicecourses.com/activity/p/16156/ Wed, 15 May 2019 19:17:44 -0400 I have worked in the medical industry for about a year and a half and would recommend students to really take the time to find an internship/co-op opportunity and to find a semester project research opportunity to determine which path…   Read more»

]]> 9740503edc657730b690fe5f2fc5266e es338 replied to the topic "Factors to look for while evaluating change request" - https://medicaldevicecourses.com/activity/p/15491/ Wed, 15 May 2019 19:06:57 -0400 I agree with previously made points. Design changes can affect several parts of the product and can create several moving parts that the project manager and team need to be aware of. First I would agree with merzkrashed is you…   Read more»

]]> bb2cbcefa40e9b0dbe1ab04bfedab9f8 es338 replied to the topic "Project Changes" - https://medicaldevicecourses.com/activity/p/15490/ Wed, 15 May 2019 19:06:57 -0400 I haven’t personally worked with an ECO, but I have seen plenty of them in my current position. I have only noticed our company producing ECOs for product in the validation and post validation stages (once the design input and…   Read more»

]]> 6f420116b03d49cb88761761d4e7faf9 es338 replied to the topic "Mapping- Gantt Chart" - https://medicaldevicecourses.com/activity/p/15336/ Wed, 15 May 2019 19:05:21 -0400 I absolutely love and live by Gantt charts. In my undergraduate studies, we would use MS Project Gantt charts and Visio high-level schedules to organize and plan the steps it takes to develop new design concepts and prototypes. I currently…   Read more»

]]> 15619f869725451aa410be5b3b40298b es338 replied to the topic "Design Change Request" - https://medicaldevicecourses.com/activity/p/15333/ Wed, 15 May 2019 19:05:20 -0400 I agree. From what I have seen in the medical industry, when a design change is necessary the steps taken depends on the stage of the project. Currently, I am working on a project that hasn’t completed it’s clinical trials…   Read more»

]]> c4f4365d76cd63b4c814e8117db53cd0 es338 replied to the topic "Change in PM" - https://medicaldevicecourses.com/activity/p/15332/ Wed, 15 May 2019 19:05:19 -0400 I have also experienced this in the industry in one of the projects I have been a part of. There was a change in PM due to resource constraints. We had a kick off meeting to introduce the new project…   Read more»

]]> 09e958c54c4f9059571fb2ab82321bca es338 replied to the topic "Discussion Topic: Integrating Six Sigma into Project Planning" - https://medicaldevicecourses.com/activity/p/15127/ Wed, 15 May 2019 19:03:16 -0400 I agree, Six Sigma is a very powerful tool for project management. The methodology of Six Sigma is DMAIC: define, measure, analyze, improve/implement, and control. Define the problem and relate it to the customer, setting the scope. Measure the impact…   Read more»

]]> e83f3794f0335e1af57ecc8dd4b2b594 es338 replied to the topic "Engineering change order" - https://medicaldevicecourses.com/activity/p/15124/ Wed, 15 May 2019 19:03:14 -0400 Engineering change orders provide documentation of corrective actions for faulty components, end of life components, or more efficient components in a medical product, ultimately increasing the product’s safety and efficiency. ECO can be used for components that need to be…   Read more»

]]> 46c1f454ae68b185135eadef2444f244 es338 replied to the topic "Project Scope: When the timeline you have doesn't work" - https://medicaldevicecourses.com/activity/p/15123/ Wed, 15 May 2019 19:03:14 -0400 I recently experienced facing a regulatory change which affected the type of clinical testing and labeling for our products. The 2016 SMBG FDA Guidance made the packaging requirements more stringent for blood glucose meters. The label of the products need…   Read more»

]]> 1f58ff84cbccf6ca879d944fff7693fa es338 replied to the topic "Challenges to Overcome" - https://medicaldevicecourses.com/activity/p/15005/ Wed, 15 May 2019 19:02:06 -0400 Sorry technical difficulties! Posted this out of order! This was meant to be after Ashley’s post… This is a really good addition to the conversation Ashley. It seems like more innovation is with start up companies, yet while the bigger,…   Read more»

]]> 71a7a2085e757e15ed50fe93187e03f8 es338 replied to the topic "Inadequate Testing" - https://medicaldevicecourses.com/activity/p/14998/ Wed, 15 May 2019 19:02:03 -0400 I agree with f-dot, I think there is a good purpose for this book to open people’s eyes to the medical industry. If a company fails a clinical trial, the results still become public which can hurt trust and confidence…   Read more»

]]> a36596346ae49d2e2c01900da724bf3e es338 replied to the topic "Does Product Classification also depend on the Material of the Product used?" - https://medicaldevicecourses.com/activity/p/14876/ Wed, 15 May 2019 19:00:59 -0400 I agree with ial4 and appreciate sharing the guidance for market approval/submission when there is a change in a medical device. Depending on the risk from the change being made and the classification of the device determines whether a interim…   Read more»

]]> ab7472f2441e2c72922c4b6467dabc78 es338 replied to the topic "Clinical Trials Discussion" - https://medicaldevicecourses.com/activity/p/14875/ Wed, 15 May 2019 19:00:58 -0400 Responding to one of bnb6’s questions, I feel clinical trials (depending on the product and its intended market) are very expensive and can be very time consuming, but are critical in proving the quality of the product. I don’t believe…   Read more»

]]> c2dddd58d42409202f44d6beedd6e38d es338 replied to the topic "''Quality Plan'' meaning ?" - https://medicaldevicecourses.com/activity/p/14871/ Wed, 15 May 2019 19:00:56 -0400 I agree with hc225 that most countries adapt the structure of their plans from the standards written in ISO13485:2016. Medical products need to be of highest quality to deliver confidence and reliability for the health care professionals and patients using…   Read more»

]]> b45a3763bee126351f82733ac065184e es338 replied to the topic "Thoughts and Questions Related to Untested Medicine" - https://medicaldevicecourses.com/activity/p/14742/ Wed, 15 May 2019 18:59:40 -0400 Acupuncture needles are regulated by the FDA, being classified as a Class II device. If the manufacturers of acupuncture needles claim treatments with their devices, then I believe the FDA would regulate the “therapy” or service differently than what is…   Read more»

]]> efdf71b6fe283da15e580f85cdbc4053 es338 replied to the topic "510(k) clearance vs. Postmarket Approval" - https://medicaldevicecourses.com/activity/p/14737/ Wed, 15 May 2019 18:59:38 -0400 FDA 510(k) submissions are for class II devices that have already been approved in the market since the FDA passed the Medical Device Amendments Act in May 28th, 1976. When submitting a 510(k), the device must be compared to other…   Read more»

]]> ea877a40b2e794f31450b40e1ff211ed es338 replied to the topic "FDA Regulations of Medical Device-Drug" - https://medicaldevicecourses.com/activity/p/14729/ Wed, 15 May 2019 18:59:34 -0400 Continuing from alexandrabuga’s response, a Request for Designation is a written to the Office of Combination Products (OCP) requesting regulatory classification to determine if it is a device, drug, and/or biologic product and which Agency will be assigned. The FDA…   Read more»

]]> 26377f661cae1a53185a48b87ed621d7 es338 replied to the topic "Ideal project team" - https://medicaldevicecourses.com/activity/p/14583/ Wed, 15 May 2019 18:58:14 -0400 I agree with your ideal skills, having a team that varies in their experience and background, works well together, and has a passion and drive in their efforts as a valuable team member. Reliability, involvement, determination, and the ability to…   Read more»

]]> 1f3c67d96e6916035d4580e72b0a8a05 es338 replied to the topic "Determining project priority" - https://medicaldevicecourses.com/activity/p/14577/ Wed, 15 May 2019 18:58:10 -0400 I believe this is a very good conversation in understanding that different cultures can be seen in project management. What I have understood from experience of myself and friends is that management plays a very critical role in the companies…   Read more»

]]> 4930c8a1e8832adfff77d7060cc72a12 es338 replied to the topic "Tests for validation and verification phase" - https://medicaldevicecourses.com/activity/p/14518/ Wed, 15 May 2019 18:57:36 -0400 In response to the experience seen in industry, I have similar input as hruship101 and srg36. Working for a global SMBG company, validation and verification (V&V) is understood to be our leading factor in producing products of high quality. Accuracy,…   Read more»

]]> 6a034b2c2e7874f0b38a6a4c1446e5ec es338 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/9253/ Mon, 03 Dec 2018 04:52:26 -0500 Dr. Simon,

I appreciate the material that you are teaching in this class as it is extremely applicable to the industry. This course has allowed be to expand my knowledge in my current position and has allowed me to use what I have learned in this class directly in the industry. Thank you for educating not only myself, but my peers in medical…[Read more]

]]> 0 dbfe3a8e50b8825e1764c6bc8329f2c4 es338 replied to the topic Anti-kickback & Stark Cases in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/9246/ Mon, 03 Dec 2018 04:25:53 -0500 False Claims Act violations can result in the following:
• Damages penalty triples the amount of money defrauded from the government
• Claim penalties from $11,000 – $22,000 for each claim that violates the False Claims Act
Anti-kickback Status (AKS) violations can result in the following:
• Criminal penalties include fines up to $25,000 and 5 yea…[Read more]

]]> 0 660ba786d437da26bcb00a88b7672759 es338 replied to the topic Your Organizational prference; but why? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/9119/ Mon, 26 Nov 2018 02:10:35 -0500 Currently, I work in a Matrix Organization which is project-based, where there is a representative per functional group that is responsible for successfully moving the project through the developmental phases and creating the documents required for the DHF. Each project is assigned a project team, where there is a selected global program lead,…[Read more]

]]> 0 201e3395ca78ea26a8f8b0ea4ecc70bc es338 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/9036/ Mon, 19 Nov 2018 04:56:43 -0500 I am surprised to hear as well that instructions for use (IFU) and labels are deemed as the least effective way to solve residual risk since the amount of effort that is taken to ensure the content on the packaging and labeling meets regulatory requirements. Regulatory and quality are heavily involved in the artwork approval process for packaging…[Read more]

]]> 0 28eec227a5fb64ffda3607c838e091a8 es338 replied to the topic Sample Size Based on Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/9033/ Mon, 19 Nov 2018 04:39:33 -0500 As hc225 mentioned, from experience in the industry, AQL levels are in place for the critical dimensions from the technical drawings of the product. Quality Control (QC) measures are conducted for every batch of product. As I have experienced with a Class I medical product in the US, but a Class II medical product in EU, sample size per QC test is…[Read more]

]]> 0 0de7716c1d4ab51ff31c804e9687e9c1 es338 replied to the topic Auditor's view of DHF / DHR in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8926/ Mon, 12 Nov 2018 04:27:53 -0500 Hello,
I have recently participated in a Medical Device Single Audit Program (MDSAP) audit and am currently preparing for the second part of the same audit within the end of this year. MDSAP is a single audit for medical devices that covers regulatory requirements for the US, Canada, Brazil, Australia, and Japan.

For more information:…[Read more]

]]> 0 eea3648da7b05f02121f1aab18a6f550 es338 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8923/ Mon, 12 Nov 2018 04:05:20 -0500 Hello,
General consequences of insufficient design controls:
• Design not meeting the needs or wants of the intended market/customer
• Faulty product in the market requiring replacements
• Product having a negative ROI
• Product success = company reputation; potentially harm the company’s identity
• Product providing misundersta…[Read more]

]]> 0 1d106b5604e86332241bbcc3cc882f19 es338 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8922/ Mon, 12 Nov 2018 04:04:02 -0500 Hello,
I have some experience developing Gantt charts through my undergraduate program and through industrial experience.
From my perspective, some important factors before starting the Gantt chart are as follows:
• Define generic key milestones of the project
• Identify target dates for the key milestones
• Define functional groups that will…[Read more]

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