Medical Device Courses | aaq2 | Activity https://medicaldevicecourses.com/members/aaq2/activity/ Activity feed for aaq2. Sat, 16 May 2026 09:37:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 2d86e7d32dba9f975a058a8e23569e3a aaq2 replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/14368/ Wed, 15 May 2019 18:55:31 -0400 Non-disclosure agreements can be defined as an agreement by which companies or various individuals agree to keep information confidential. NDA is a contract and not a law. Contracts are interpreted in different manners depending on the state law and interpretations…   Read more»

]]> b4fac79407550b2cdf7ed8ba5611f1f1 aaq2 replied to the topic "Recent Examples of Kickback Allegations" - https://medicaldevicecourses.com/activity/p/14367/ Wed, 15 May 2019 18:55:30 -0400 Even though this article is dated 2009, Pfizer was asked to pay $2.3 billion dollars to settle allegations of kickbacks in off-label marketing campaign. Per the article 49 states and the federal government reached the largest-ever settlement at the time…   Read more»

]]> aa8c051b60c050d01f4c945d134345a7 aaq2 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/14366/ Wed, 15 May 2019 18:55:30 -0400 This course has shed some light on the medical device industry. This course gives you the opportunity to have some understanding of what is expected of you when you work for a medical device company. When I took my first…   Read more»

]]> 875a5482aadfcaaaf98db677ed18fd10 aaq2 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/14254/ Wed, 15 May 2019 18:54:28 -0400 Select your team by choosing the right people. Select these individuals for their skills and abilities. One does not necessarily need the most qualified person but one should consider an individual who is specific for the project. At some point…   Read more»

]]> d7985a0bf15024a7ed16b4f6154af56c aaq2 replied to the topic "Collaboration projects" - https://medicaldevicecourses.com/activity/p/14253/ Wed, 15 May 2019 18:54:27 -0400 I also agree with Adrian. I have worked with establishments where different companies have come together to work on a project and some of these companies have actually merged. Believe it or not basic communication becomes a problem. This lack…   Read more»

]]> f24b46df4cff0601e0216822496a77b0 aaq2 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/14252/ Wed, 15 May 2019 18:54:27 -0400 I used to work in a functional organization where the functional head has a lot of power. From what I have observed they make most of the decisions. They choose who can work on what project and have the power…   Read more»

]]> c3b86df640f7a0741590d1d1743903ec aaq2 replied to the topic "How to run a risk management meeting ?" - https://medicaldevicecourses.com/activity/p/14095/ Wed, 15 May 2019 18:51:51 -0400 Before the meeting the risk manager should compile a list of risks The manager should also entertain a list of risks from the team Categorize the risks for easy identification of duplicates The manager should create a chart which will…   Read more»

]]> a55c3a11d6e75355ef16bef9cb8985e5 aaq2 replied to the topic "Manage Risk" - https://medicaldevicecourses.com/activity/p/14094/ Wed, 15 May 2019 18:51:51 -0400 For low severity I would rely on accepting the risk. Accepting the risk occurs when the price to pay for managing a type of risk is accepted due to the risk involved not adequate enough to warrant the added cost…   Read more»

]]> 7d7c0962f177325d37eacb241a78a6d8 aaq2 replied to the topic "Discussion Topic: Risk Management, Risk Analysis" - https://medicaldevicecourses.com/activity/p/14093/ Wed, 15 May 2019 18:51:50 -0400 Risk management regulation is based on safety, quality and efficacy. It requires that the company creates a risk management policy that includes planning of risk management, risk analysis, risk evaluation, risk controls, overall residual risk acceptability, risk management report and…   Read more»

]]> c27cee41bfdf38773ab5681edbcb089e aaq2 replied to the topic "Auditor's view of DHF / DHR" - https://medicaldevicecourses.com/activity/p/13998/ Wed, 15 May 2019 17:10:17 -0400 Device history file – Each medical device has a document that displays the design history. This document is initiated as the design starts and moves on through development process. According to the FDA the design history should contain all the…   Read more»

]]> eb3e2e2a9aaf0b053f22a08779a4ade3 aaq2 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/13997/ Wed, 15 May 2019 17:10:16 -0400 For the Gantt chart you need to think through all the tasks involved in your project. The process will include working out who is responsible for each task and how long the task will take. One should also include the…   Read more»

]]> aa88319bec28ab835568b8ae7e4bd062 aaq2 replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/13989/ Wed, 15 May 2019 17:10:12 -0400 Project review meetings bring together the best employees the company has to offer. The idea is to evaluate the design against its requirements in order to verify the outcomes of previous activities and identify issues before committing. The design review…   Read more»

]]> 994275e743da0d178ef45e141a3f8ef8 aaq2 replied to the topic "What FDA Looks For In A Design Control System ?" - https://medicaldevicecourses.com/activity/p/13847/ Wed, 15 May 2019 17:08:46 -0400 Per the FDA site the regulation dos not prescribe the practices that must be used instead it establishes a framework that manufacturers must use when developing and implementing design controls. To add to what was posted by hv24, a sample…   Read more»

]]> 8ab9c327721538c9961d0fc5a25ee13f aaq2 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/13846/ Wed, 15 May 2019 17:08:45 -0400 If one desires to reproduce the device then the DHF will be the way to go. For a summary I believe the tech file would be more useful. The tech file might eliminate the cumbersome information that is not required…   Read more»

]]> 6ca4c91e44d4f399ddd230dc1cff2c74 aaq2 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/13836/ Wed, 15 May 2019 17:08:40 -0400 Meeting minutes are very important in every company I have worked for since graduating. The current company I work for uses sharepoint to track all meeting minutes. All changes to regulations that are discussed are documented. On several occasions I…   Read more»

]]> a43551e32bfa288956cf3986c3c5b5f5 aaq2 replied to the topic "Clinical Trial Roles" - https://medicaldevicecourses.com/activity/p/13689/ Wed, 15 May 2019 17:07:16 -0400 Being a research coordinator would be my role of interest. This position requires that the study data is accurately captured and reported. The role also involves reporting any study or participant issues, maintaining regulatory files at the study site and…   Read more»

]]> bc975d1f96e541ed07d94832b4d7187f aaq2 replied to the topic "Discussion Topic: Having a "clinical background"" - https://medicaldevicecourses.com/activity/p/13688/ Wed, 15 May 2019 17:07:16 -0400 Having a clinical background may be advantageous to understanding all aspects of the research. It may also be advantageous when dealing with patient care, collecting data on treatments effectiveness, studying and reading medical journals, evaluation of previous research and research…   Read more»

]]> e83a59b00513dcb4370957f384210f57 aaq2 replied to the topic "Clinical Studies" - https://medicaldevicecourses.com/activity/p/13687/ Wed, 15 May 2019 17:07:16 -0400 A clinical trial has various advantages depending on which side of the fence you one may stand. It may serve as an additional source of income for doctors and nurses. At the same time physicians and nurses may be delighted…   Read more»

]]> 9f01b1eb7230929d65a156c982bb7d86 aaq2 replied to the topic "Discussion Topic: The Fifth "P" of Marketing" - https://medicaldevicecourses.com/activity/p/13543/ Wed, 15 May 2019 17:05:55 -0400 Currently some of the strategies being used include multi-channel analytics. This process uses multiple sets of data from different sources which are linked and housed together. Businesses then use this information to interact with clients through the use of Apps,…   Read more»

]]> f748e31fc947f86339c38ed7a683e351 aaq2 replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" - https://medicaldevicecourses.com/activity/p/13542/ Wed, 15 May 2019 17:05:54 -0400 What is EI? EI is defined as being able to understand moods, behavior and impulses and control them to match a certain situation. One should possess the capability to exhibit mature emotions to better understand, negotiate, and sympathize with others….   Read more»

]]> def57a9dfba75aaf3f919c97044498df aaq2 replied to the topic "Discussion Topic: Mission and Vision statements" - https://medicaldevicecourses.com/activity/p/13541/ Wed, 15 May 2019 17:05:54 -0400 Mission statement – a brief summary on the values of a company/organization Vision statement – A depiction of what a company/organization strives to achieve in the future. It is meant to function as a guide for making future decisions. They…   Read more»

]]> e853c16218ec26a8446ff69430116545 aaq2 replied to the topic "Types of Corporations" - https://medicaldevicecourses.com/activity/p/13405/ Wed, 15 May 2019 17:04:38 -0400 I would take the LLC route: LLCs protect its members from being held personally responsible for the actions of the LLC. The limited liability protects you from the personal risks involved if a lawsuit were to arise concerning your business…   Read more»

]]> 045c9dd99d209ef3933749f7831ee7c6 aaq2 replied to the topic "Discussion Topic: Inc. vs. LLC in the US" - https://medicaldevicecourses.com/activity/p/13404/ Wed, 15 May 2019 17:04:37 -0400 A medical company of that size and revenue should exist as in incorporation vs an LLC. Some of the benefits of owning and incorporation over an LLC include the following. Corporation owners enjoy limited liability protection, and are usually not…   Read more»

]]> e010a0a40a77c753abe7ac4685a2c109 aaq2 replied to the topic "Discussion Topic: Exercise your research skills" - https://medicaldevicecourses.com/activity/p/13403/ Wed, 15 May 2019 17:04:37 -0400 Walmart Return on Equity: Return on equity expresses net income as a percentage of shareholders equity. ROE values about 9-10% are considered strong and ROE above 25% is considered excellent. Walmart has an ROE of 17.5 Debt to equity ratio:…   Read more»

]]> 807f3e97a7bb167b0c707d312f2ac679 aaq2 replied to the topic "Issues with the Quality Department" - https://medicaldevicecourses.com/activity/p/13260/ Wed, 15 May 2019 17:03:22 -0400 Too much documentation: Many companies have too many documents that tend to hinder the function of QA/QC departments. Some major companies have excessive documentation that employees may become overwhelmed and possibly lose interest in the quality management system and therefore…   Read more»

]]> ae2a9df7514795e8ca9d445765bd9452 aaq2 replied to the topic "Your Ideas about Improving Quality Control" - https://medicaldevicecourses.com/activity/p/13259/ Wed, 15 May 2019 17:03:21 -0400 One can always improve a department by defining processes – look at every aspect of production process and clearly define and streamline processes. Always hire qualified candidates who possess the qualification, knowledge, skill and experience. Furthermore, always provide in house…   Read more»

]]> b1e34d90efb1b433521e10771f035314 aaq2 replied to the topic "Discussion Topic: The cost of Quality" - https://medicaldevicecourses.com/activity/p/13258/ Wed, 15 May 2019 17:03:21 -0400 The only way one should see this as a burden is if they have no idea of the consequences. Yes, QA/QC might cause you to rework, may cause delays, re-designs, failure analysis, retesting, downtime and lack of flexibility but imagine…   Read more»

]]> 4924f1337a28a2bb7bea62596bf9fcaf aaq2 replied to the topic "Discussion Topic: The de Novo 510(k) Process" - https://medicaldevicecourses.com/activity/p/13144/ Wed, 15 May 2019 17:02:22 -0400 De novo classification (513(f)(2) of the Federal Food, Drug, and cosmetic act) provides a pathway to Class I or Class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety…   Read more»

]]> e2cd9340ec631f5d90e9825a5c441f32 aaq2 replied to the topic "Discussion Topic: Antibiotic-Releasing Hip Stem" - https://medicaldevicecourses.com/activity/p/13111/ Wed, 15 May 2019 17:02:02 -0400 It falls under combination products per the definitions below: Combination products are products that combine drugs, devices and or biological products. 1. A product comprised of two or more regulated components 2. Two or more separate products packaged together in…   Read more»

]]> 6a75e731d60bf8adab788b447a306486 aaq2 replied to the topic "Discussion Topic: e-cigarettes" - https://medicaldevicecourses.com/activity/p/13108/ Wed, 15 May 2019 17:02:01 -0400 The FDA as of 22 June, 2009 was granted the authority to regulate tobacco products. The part of the FDA that regulates tobacco products is known as the center for tobacco products. This department was officially established to implement the…   Read more»

]]> bdfb2aa8cefb37cc22754675f8d8457b aaq2 replied to the topic "Discussion Topic: e-cigarettes" - https://medicaldevicecourses.com/activity/p/13107/ Wed, 15 May 2019 17:02:00 -0400 The FDA as of 22 June, 2009 was granted the authority to regulate tobacco products. The part of the FDA that regulates tobacco products is known as the center for tobacco products. This department was officially established to implement the…   Read more»

]]> 52f2a0fa9ddbc6006f1c07a906911cee aaq2 replied to the topic "Research for the Fututre or Now?" - https://medicaldevicecourses.com/activity/p/12965/ Wed, 15 May 2019 17:00:48 -0400 Even though research for both generations are important, I would rather work on research for the present generation. My goal is to help and provide solution for problems that are currently at hand. Just imagine being able to cure a…   Read more»

]]> c5e32aa93fd7bd867015e92706553fda aaq2 replied to the topic "Discussion Topic: Beyond experimental design issues" - https://medicaldevicecourses.com/activity/p/12935/ Wed, 15 May 2019 17:00:30 -0400 The pitfall to awarding the trial to this university could bring about ethical issues. With so many ties to the university one could assume possible manipulation of data to favor the clinical trial. Also, the risk of kickbacks associated with…   Read more»

]]> 1b90913a8f3b15e7c014bbaf5bd9b3f1 aaq2 replied to the topic "Discussion Topic: Brand new biomaterial" - https://medicaldevicecourses.com/activity/p/12934/ Wed, 15 May 2019 17:00:30 -0400 Various tests need to determine the safety of the product before use in clinical studies (21 CFR 312.23(a)(8)). A complete description of material composition should be made available, detailed specification for formulation and chemical composition. The preclinical data is usually…   Read more»

]]> b5fc43d2cbcaf553990563d1a1b0cf99 aaq2 replied to the topic "Milestones Missed: Failure or Success?" - https://medicaldevicecourses.com/activity/p/12871/ Wed, 15 May 2019 16:59:51 -0400 Missing a milestone may not be a failure if one meets the agreed deadline set in communication with a client. Milestones are put in place to ensure key deliverables are achieved according to the timelines set by the project manager….   Read more»

]]> 9a639e0a6ddb8c4eac571d2443585838 aaq2 replied to the topic "Discussion Topic: Portfolio, Program, Strategy" - https://medicaldevicecourses.com/activity/p/12813/ Wed, 15 May 2019 16:59:21 -0400 A portfolio is a view of all programs or projects that a company has in its pipeline to meet business objectives. Portfolio strategy involves the path the investors can take to use the company’s assets to attain financial goals while…   Read more»

]]> a6512cf9fe54afd5998187fd62112ce5 aaq2 replied to the topic "Discussion Topic: Project Management in a medical device setting" - https://medicaldevicecourses.com/activity/p/12806/ Wed, 15 May 2019 16:59:18 -0400 Challenges that project managers for medical devices face differ from those that construction project managers face in a few ways. Construction project managers and medical device mangers both have to ensure the project is on track and according to plan….   Read more»

]]> d2c7bafbd3d63f2e957be46eecc3a8bc aaq2 replied to the topic "Discussion Topic: Practical vs. Informational courses" - https://medicaldevicecourses.com/activity/p/12626/ Wed, 15 May 2019 16:57:41 -0400 I believe the ratio should be at least 50/50 or with the practical aspect having a higher percentage. After graduating college I thought I had learned a lot; little did I know my learning was just about to begin. Even…   Read more»

]]> ae9cc434f25fe8ab6f82c9167d9352e5 aaq2 replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5415/ Wed, 29 Nov 2017 13:21:09 -0500 Non-disclosure agreements can be defined as an agreement by which companies or various individuals agree to keep information confidential. NDA is a contract and not a law. Contracts are interpreted in different manners depending on the state law and interpretations vary from state to state. Patent law, which is federal, is interpreted uniformly…[Read more]

]]> 0 1694f4fcbc8e455d3fc9f23adebd15c4 aaq2 replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5414/ Wed, 29 Nov 2017 12:52:22 -0500 Even though this article is dated 2009, Pfizer was asked to pay $2.3 billion dollars to settle allegations of kickbacks in off-label marketing campaign. Per the article 49 states and the federal government reached the largest-ever settlement at the time over allegations of healthcare fraud. Pfizer Inc settled civil and criminal allegations that…[Read more]

]]> 0 b9d9bf054de21f0b601d04e49beb49cd aaq2 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5413/ Wed, 29 Nov 2017 12:42:01 -0500 This course has shed some light on the medical device industry. This course gives you the opportunity to have some understanding of what is expected of you when you work for a medical device company. When I took my first job after my graduating from college I had no idea what to expect. All I wanted to do was to get a job and start making money…[Read more]

]]> 0 882fa6f2b70e54dcec757b8b15830361 aaq2 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5292/ Sun, 26 Nov 2017 00:08:58 -0500 Select your team by choosing the right people. Select these individuals for their skills and abilities. One does not necessarily need the most qualified person but one should consider an individual who is specific for the project. At some point in my career I was told to concentrate on the skills required for the job and not to concentrate on…[Read more]

]]> 0 fdc21b27f38f0986591f16abc985a0c9 aaq2 replied to the topic Collaboration projects in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5291/ Sat, 25 Nov 2017 23:33:30 -0500 I also agree with Adrian. I have worked with establishments where different companies have come together to work on a project and some of these companies have actually merged. Believe it or not basic communication becomes a problem. This lack of communication may create distrust and uncertainty in a workplace. This often leads to lower employee…[Read more]

]]> 0 9a7ed921ebbc6c19c81473523d63aebe aaq2 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5290/ Sat, 25 Nov 2017 23:14:43 -0500 I used to work in a functional organization where the functional head has a lot of power. From what I have observed they make most of the decisions. They choose who can work on what project and have the power to determine your future within the company. In this kind of establishment if the functional head likes you, you are bound to succeed and…[Read more]

]]> 0 4d1947b211739bfd4eb5cf7877ca7f7c aaq2 replied to the topic How to run a risk management meeting ? in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5127/ Thu, 16 Nov 2017 01:42:34 -0500 Before the meeting the risk manager should compile a list of risks
The manager should also entertain a list of risks from the team
Categorize the risks for easy identification of duplicates
The manager should create a chart which will determine the region the risks fall in (this will help determine the probability and impact for that risk)
Risks…[Read more]

]]> 0 89572e3fd5bf440a6378a66f64665691 aaq2 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5126/ Thu, 16 Nov 2017 01:29:06 -0500 For low severity I would rely on accepting the risk. Accepting the risk occurs when the price to pay for managing a type of risk is accepted due to the risk involved not adequate enough to warrant the added cost it will take to avoid that risk. This would be a good strategy to implement if it involves a very small risk.

Risk control involves…[Read more]

]]> 0 afb0c1094300fa560a390c455caf114c aaq2 replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5125/ Thu, 16 Nov 2017 00:06:38 -0500 Risk management regulation is based on safety, quality and efficacy.
It requires that the company creates a risk management policy that includes planning of risk management, risk analysis, risk evaluation, risk controls, overall residual risk acceptability, risk management report and production and post production information

]]> 0 608cf24018ccb5718df3c5094f790762 aaq2 replied to the topic Auditor's view of DHF / DHR in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5019/ Sun, 12 Nov 2017 03:19:33 -0500 Device history file – Each medical device has a document that displays the design history. This document is initiated as the design starts and moves on through development process. According to the FDA the design history should contain all the records necessary to demonstrate the design was developed in accordance with the designed plan and…[Read more]

]]> 0 9f9118490e915e061ad59659df9ef922 aaq2 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5018/ Sun, 12 Nov 2017 02:57:35 -0500 For the Gantt chart you need to think through all the tasks involved in your project. The process will include working out who is responsible for each task and how long the task will take. One should also include the problems a team may encounter. A detailed thinking will help ensure that a designed schedule is workable, and that the right…[Read more]

]]> 0 171e1dc7282dedb9408558e3694e32af aaq2 replied to the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5009/ Sun, 12 Nov 2017 01:00:45 -0500 Project review meetings bring together the best employees the company has to offer. The idea is to evaluate the design against its requirements in order to verify the outcomes of previous activities and identify issues before committing. The design review evaluates a design against its requirements by taking into consideration the physical tests…[Read more]

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