https://medicaldevicecourses.com/members/merzkrashed/activity/ Activity feed for merzkrashed. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 887b5d7d907ae1b9405177c7ac8a376b https://medicaldevicecourses.com/activity/p/15962/ Wed, 15 May 2019 19:15:39 -0400 When preparing a budget for a clinical trial you need to perform an internal cost analysis by evaluating your study specifications and determining expected enrollment. You need to determine how long the study will take?, Are you able to find…   Read more»

]]> b4d442826e1833a25e796d43a06c57b1 https://medicaldevicecourses.com/activity/p/15961/ Wed, 15 May 2019 19:15:38 -0400 Resources, budget,responsibilities and skills are main factors to determine how to manage a project in a small or a large company. Effective project management in a small business means reaching the project goals on time and within budget, despite having…   Read more»

]]> 6a0abc896f8c368f23d10a10107d8285 https://medicaldevicecourses.com/activity/p/15960/ Wed, 15 May 2019 19:15:38 -0400 Deciding on when to outsource clinical trial or insource depending on the project, capabilities and resources needed. I think insourcing is more expensive for an organization as a result of implementing new processes to start a different division of the…   Read more»

]]> d97e5c8df48e7a8f45b74eaab3671366 https://medicaldevicecourses.com/activity/p/15958/ Wed, 15 May 2019 19:15:37 -0400 When equipment is moved to a new location, installation and operation should be re-qualified. By comparing data from the original installation and operation qualification (IQ and OQ) and the re-qualification, the manufacturer can determine whether there have been any changes…   Read more»

]]> a23a154978544a7601f2ed30663015e4 https://medicaldevicecourses.com/activity/p/15957/ Wed, 15 May 2019 19:15:36 -0400 Example: Placebos Study Placebos are necessary for studies and clinical trials. When doing statistical analysis, you’ll have a controlled-group that’ll receive the drug or device in question for actual treatment and perhaps another group that’ll receive a type of “sugar…   Read more»

]]> a52943c57c1b1257def1018e4d992eb3 https://medicaldevicecourses.com/activity/p/15952/ Wed, 15 May 2019 19:15:34 -0400 Actually AMDD very useful class. I learned a lot about the regulations and QSR in US and regulations in EU as well. Participation & Simulations great features for the class. This class took me to the real world problems in…   Read more»

]]> b01b6677c9fa0321a64ead3bcc9ebfdd https://medicaldevicecourses.com/activity/p/15940/ Wed, 15 May 2019 19:15:26 -0400 For me I will choose CRA , as a CRA you will do studies may involve the development of a new medication or assessment of a new medical device.A CRA is one of the clinical science jobs that offers many…   Read more»

]]> dc60d8b5b7a750971b426ebf3b0ef4a8 https://medicaldevicecourses.com/activity/p/15937/ Wed, 15 May 2019 19:15:25 -0400 Motivation for a project manger is the key for success also Communication is another important key for a project manager. Project managers must communicate their visions clearly and project a project’s scope in a way that everyone can understand. They…   Read more»

]]> 66f787347115276f2f712d56aa722ace https://medicaldevicecourses.com/activity/p/15931/ Wed, 15 May 2019 19:15:22 -0400 For me I would like to work as an engineer and after 4-7 years I would like be a manager. Also, I think after getting more experience in the field I can start my own company. My goal to start…   Read more»

]]> 7976eaa5d1fe055436a039fd6b0b7ae1 https://medicaldevicecourses.com/activity/p/15880/ Wed, 15 May 2019 19:14:54 -0400 The definition of A Significant Risk (SR),is a device presents a potential for serious risk of health, safety and welfare of a subject, and are intended to be used as an implant and; purported to support or sustain human life;…   Read more»

]]> 08b641b63a3f6e54afbc2f506e8c3a3f https://medicaldevicecourses.com/activity/p/15878/ Wed, 15 May 2019 19:14:53 -0400 clinical trials costs are largely driven by labor, much of these savings are from lower salaries to physicians, nurses, and trial coordinators. It is true that some regions of the globe are vastly more expensive than others to conduct clinical…   Read more»

]]> b8a800f1e2d6ac36de701c3e6bbe1ffd https://medicaldevicecourses.com/activity/p/15877/ Wed, 15 May 2019 19:14:52 -0400 During your work as a CRA, you will do studies may involve the development of a new medication or assessment of a new medical device.A CRA is one of the clinical science jobs that offers many opportunities to choose the…   Read more»

]]> 8367963ff6cb35768824861b50f0b348 https://medicaldevicecourses.com/activity/p/15743/ Wed, 15 May 2019 19:13:28 -0400 Think about it, if no GMP!, Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to…   Read more»

]]> 41f4dfe7942fc2df4889561e709e6cfe https://medicaldevicecourses.com/activity/p/15742/ Wed, 15 May 2019 19:13:28 -0400 Hi thuytienlecao Internal audits could be done by the manufacturer itself or by hiring auditor.Both 21 CFR Part 820, the Quality System Regulation (QSR), and ISO 13485:2003 require internal quality audits. In QSR, the audits have two primary purposes: Assure…   Read more»

]]> 149aa8cded0264345c7e8da66c403b7e https://medicaldevicecourses.com/activity/p/15741/ Wed, 15 May 2019 19:13:27 -0400 1)Who should do the communication on a project dependent on the organization set-up? Communication in any project is an essential tool for a PM, also regardless of your role on the project, you must learn how to communicate effectively (with…   Read more»

]]> 489eb3a1144171fc3756c09ffdfe4d8e https://medicaldevicecourses.com/activity/p/15727/ Wed, 15 May 2019 19:13:19 -0400 Adding to the discussion, systems approach to project management enables the project manager to constantly evaluate the needs of the customer and the end results that are needed to be achieved in terms of resources, budget and time. A successful…   Read more»

]]> 9f57c5950bcd155e67276d9bc7256dae https://medicaldevicecourses.com/activity/p/15721/ Wed, 15 May 2019 19:13:16 -0400 Different risk analysis methods like FMECA,FMEA includes (FMEA – PFMEA, Design FMEA – DFMEA), Root Cause Analysis (RCA),RCM (Reliability Centered Maintenance), and Risk and control self assessment (RCSA). For example: FMEA Failure mode and effects analysis. Benefits: – FMEA is…   Read more»

]]> 391c88c23df0332bd62c40e0da5b09bb https://medicaldevicecourses.com/activity/p/15695/ Wed, 15 May 2019 19:12:57 -0400 CAPA is required under 21CFR820.100 It requires manufacturers of medical devices to have clearly documented procedures for corrective and preventive action. CAPA is important to continuous improvement processes. CAPA can help to lower the cost of quality because of it…   Read more»

]]> b41cc60b4e32e00fa5fcb5ceef9321dd https://medicaldevicecourses.com/activity/p/15691/ Wed, 15 May 2019 19:12:55 -0400 I thing the biggest advantage for internal audit, it gives you a chance to verify that your CAPA have been completed effectively and on time or not!. Also, the ability to identify non-compliance thing in the product and provide recommendations…   Read more»

]]> 5de478b9c25912ee5f4187f73e9f3f30 https://medicaldevicecourses.com/activity/p/15686/ Wed, 15 May 2019 19:12:53 -0400 GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances errors or problems from a medical device for example. GMP is also sometimes referred to as “cGMP”. the “c” stands for “current,” reminding manufacturers that…   Read more»

]]> 5bf309cac37f61e6c9730998b21c4d66 https://medicaldevicecourses.com/activity/p/15653/ Wed, 15 May 2019 19:12:31 -0400 Budget cuts doesn’t affect the cost estimation of the project. However it does affect the scope or quality of the project. A good project manager needs to resist that pressure and make sure that any cuts in project spending are…   Read more»

]]> ea8b7681697c7f3dc94ede0ef756a827 https://medicaldevicecourses.com/activity/p/15652/ Wed, 15 May 2019 19:12:31 -0400 In the closing phase closing phase process, all documents of the project both in terms of device delivery, and project management delivery must be completed. Project actual results are reported and documented, project contracts are closed, and lessons learned documents…   Read more»

]]> 83b89f2a269a76532b69c96c5b0680ff https://medicaldevicecourses.com/activity/p/15651/ Wed, 15 May 2019 19:12:30 -0400 I think all the factors listed are very important for a project, and I think the most important thing is to Develop clearly defined plans with assigned responsibilities. For each task in thee project must be identified in your data…   Read more»

]]> 66f5723b9afd1f04251b1200ba3a9ddc https://medicaldevicecourses.com/activity/p/15649/ Wed, 15 May 2019 19:12:29 -0400 Actually all the factors listed above are a very important tools for a successful product manager, but I think its very important for the product manager to Stay informed about industry and market data, because better pricing and better service…   Read more»

]]> 719fd5bec50f4f4914aad058cdedf542 https://medicaldevicecourses.com/activity/p/15642/ Wed, 15 May 2019 19:12:25 -0400 Interpersonal skills is very important in negotiation. I believe a good negotiator should have some qualifications- for example: – Preparation and planning skill. – knowledge of the subject matter being negotiated. – Ability to think clearly and rapidly under pressure…   Read more»

]]> f085af8b3a4ed94111aae7a825ab98bd https://medicaldevicecourses.com/activity/p/15567/ Wed, 15 May 2019 19:07:43 -0400 Introduction stage of a product life cycle, its a very important stage in the product life cycle, because the product manager should focus on marketing,advertising, pricing , distribution, and promotion to sell the product. In the introduction stage limited competition,…   Read more»

]]> 3e8d356f725c1f5a0773c81f9de389ed https://medicaldevicecourses.com/activity/p/15557/ Wed, 15 May 2019 19:07:37 -0400 The FDA recalled GE MRI in 2015. Reason for Recall: Some MRI units may have been modified by service personnel or by equipment users to disable the Magnet Rundown Unit (MRU). The MRU is one method used to shut off…   Read more»

]]> bb1c725cbe5df9cafc57fa59144d43b2 https://medicaldevicecourses.com/activity/p/15486/ Wed, 15 May 2019 19:06:53 -0400 Product development phase is the most important role in the product life cycle. As Dr. Simon mentioned, in the development phase you start to do: Market Research, Design Control, Design Transfer, Approval, and IQ OQ & PQ. Because of the…   Read more»

]]> 53253b3cb343ebd11c92471003796a9a https://medicaldevicecourses.com/activity/p/15466/ Wed, 15 May 2019 19:06:39 -0400 First of all you need to think about the reason for any change, also if the change is essential or no?. If the change will add improvement to the project or or improvement for the device ? To evaluate a…   Read more»

]]> 6ec75492f1d4b84d7bc9cba0706502a1 https://medicaldevicecourses.com/activity/p/15441/ Wed, 15 May 2019 19:06:25 -0400 In monitoring and controlling phase of the project management lifecycle ensures that the project performance is monitored and adjustments to the project schedule are made as needed. According to PMBOK, in the monitoring and controlling processes accomplish three things: -…   Read more»

]]> e552ba9ff44a32a7912348450defb5c0 https://medicaldevicecourses.com/activity/p/15434/ Wed, 15 May 2019 19:06:20 -0400 Scheduling utilizes a combination of work breakdown structure and project information, these include: tasks, key tasks, project types, location, project characteristics,WBS, and time and staffing standards. As a project manager you need to plan for the unexpected things!.Things happen during…   Read more»

]]> be48dacaec9b14e47243796eb917992f https://medicaldevicecourses.com/activity/p/15430/ Wed, 15 May 2019 19:06:18 -0400 I think validation is the most important process in a design control. As a project manager you need to know what is validation mean and how you validate a product. You need to make sure the device you have created…   Read more»

]]> 47fd130bb8b17ed6cf1d41420d9672cb https://medicaldevicecourses.com/activity/p/15380/ Wed, 15 May 2019 19:05:45 -0400 When it comes to a timeline change in a project, this will causing delay in the project. If you are a project manager, you need to create accurate project timeline, that will help you reach your goals as planned. A…   Read more»

]]> 893b5a83d90cd5dea6b021df2ddc9bc7 https://medicaldevicecourses.com/activity/p/15341/ Wed, 15 May 2019 19:05:24 -0400 An example of a combination product: Bone morphogenetic proteins (BMPs are a class of proteins) that induce bone formation. New technology in orthopedic repair combines BMPs with a carrier matrix to create a combination product that, when implanted in a…   Read more»

]]> fa87af144da7bdfe521efd748779981a https://medicaldevicecourses.com/activity/p/15339/ Wed, 15 May 2019 19:05:23 -0400 As we learned from Simulation 2, ,the IQ, OQ, and PQ required for proper inspection. During the validation process all the data need to be analyzed and documented. You should analyze each input and fully verify the results. Validation is…   Read more»

]]> e06b95a334d7f7779f75e1e8b7966365 https://medicaldevicecourses.com/activity/p/15308/ Wed, 15 May 2019 19:05:05 -0400 Validation is the process of making sure that you have objective evidence that user needs and intended uses are met. It is usually done by tests, inspections, and analysis. However, the target of the validation is to make sure the…   Read more»

]]> 4fbd23bb6a7d1fb093e7803e68d13794 https://medicaldevicecourses.com/activity/p/15297/ Wed, 15 May 2019 19:04:58 -0400 Actually, the FDA reviews the validation of the manufacturing processes. According to 21 CFR 820.75, which states that “where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated”. The validation…   Read more»

]]> d3025a834cbbf6ae44a59d9fb3dc4cd1 https://medicaldevicecourses.com/activity/p/15295/ Wed, 15 May 2019 19:04:57 -0400 An example for managing the risk for a medical device: There is a medical device called “PEMF: Pulsed ElectroMagnetic Field”, this device is being used for bone simulation (bone healing). In terms of risk management, for example, risk of Toxicity,…   Read more»

]]> 62479ddf46023596138e2ce7ad10c86b https://medicaldevicecourses.com/activity/p/15294/ Wed, 15 May 2019 19:04:57 -0400 As we learned, in the planning phase its important to do: 1- Scope Statement: the statement thoroughly describes the project, and objectives of the project . The statement also describes the project’s context. When everyone agrees with the statement, the…   Read more»

]]> 0b4fb90f48eae7c51aa69ae04d216d56 https://medicaldevicecourses.com/activity/p/15230/ Wed, 15 May 2019 19:04:16 -0400 Regarding to risk management, as we learned in Week 5, in project management plan you need to measure the risk, Assess, Evaluate, and finally how to manage the risk. By the time a risk actually occurs on any project, it’s…   Read more»

]]> d92e94ca22ccf930bdd17143dbacf838 https://medicaldevicecourses.com/activity/p/15168/ Wed, 15 May 2019 19:03:39 -0400 As Dr.Simon mentioned, if you failed to plan so you planning to fail. Planning phase is very important in any Medical Device project. Its important to identify critical interfaces in your project, resources you need, milestones you need to achieve…   Read more»

]]> 55fce8b2ff26aa8130a480039c803dbf https://medicaldevicecourses.com/activity/p/15166/ Wed, 15 May 2019 19:03:37 -0400 Adding to the discussion, another pitfall in Gantt chart that if you have poorly defined CAPA time-frames. CAPA which means establishing a corrective and preventive action system, which is required in (QSR) a quality system regulation for medical device for…   Read more»

]]> b7d798e1d14bcae96f86ce72ca14c3f5 https://medicaldevicecourses.com/activity/p/15164/ Wed, 15 May 2019 19:03:36 -0400 I think re-validation is required or not depends on the product. So, you need to ask some questions about your medical device, is it something like class I devices, like tongue depressor for example, or it is a class III…   Read more»

]]> 53d94eb9540560a1aa30992ff02da1b6 https://medicaldevicecourses.com/activity/p/15163/ Wed, 15 May 2019 19:03:36 -0400 Hi srg36, I think implantable orthopedic medical devices is the most highly regulated medical devices in the market. As we learned form the validation process lecture, Validation is to ensure that the medical device meets the user requirements and the…   Read more»

]]> c08ef6b5d633f457e76f1f22c3a379b4 https://medicaldevicecourses.com/activity/p/15068/ Wed, 15 May 2019 19:02:45 -0400 An engineering change order (ECO) is a documentation packet that outlines the proposed change, lists the product parts that would be affected. ECOs are used to make modifications to components, assemblies, associated documentation and other types of product information. A…   Read more»

]]> 40c57bb4ac24c03280fe461ae8c7e3a6 https://medicaldevicecourses.com/activity/p/15019/ Wed, 15 May 2019 19:02:14 -0400 Dr.Simon mentioned (in Week 3) about DHF, Design History File is required by law in 21CRF820.3(e) – “a compilation of records which describes the design history of a device”. Also, the DHF should contain some basic documents: PDF, DDP, DID…   Read more»

]]> d63c1017e6ed3d64852b42feb7439596 https://medicaldevicecourses.com/activity/p/15018/ Wed, 15 May 2019 19:02:13 -0400 Its very important on the validation process to make sure that the output equal to the user needs!. Before your company start marketing for a medical device, a successful validation should be submitted to the FDA according to FDA 21…   Read more»

]]> f0fed6ba4c83acfda008374b0a099b67 https://medicaldevicecourses.com/activity/p/14964/ Wed, 15 May 2019 19:01:46 -0400 Adding to the discussion, from my academic experience, for the documentation for any test done for a medical device,in general the risk management file which is done by QA department. For example, a medical electrical device evaluated according to standard…   Read more»

]]> 9a4351277677e9201c71712440fd0710 https://medicaldevicecourses.com/activity/p/14938/ Wed, 15 May 2019 19:01:33 -0400 The Standard Operating Procedures (SOP) as SOPs are often used to demonstrate compliance with the regulation or operational practices and to document how tasks must be completed at any organization. I think SOPs is not required in the research role…   Read more»

]]> d460a5a7b96bba5b55a48182248a972c https://medicaldevicecourses.com/activity/p/14906/ Wed, 15 May 2019 19:01:15 -0400 From my experience, I worked for a project-base company before, project-base company is easy to work with, but sometimes sometimes closing a project can mean losing your job or wait for next project which loosing time and money. In project-based…   Read more»

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