https://medicaldevicecourses.com/members/sanam/activity/ Activity feed for Sk90. Sat, 25 Apr 2026 02:21:41 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7ae03af9617e9772f1d5fd975ba3a695 https://medicaldevicecourses.com/activity/p/18314/ Wed, 15 May 2019 21:47:13 -0400 Selecting the right CRO to manage a clinical trial can be a critical decision in the program’s successful outcome. It is important to consider the experience of CRO in that particular area and important to consider the financial stability of…   Read more»

]]> f2b7cb3cbb6ed3909039578ee78416a2 https://medicaldevicecourses.com/activity/p/18301/ Wed, 15 May 2019 21:47:06 -0400 FDA and manufacturer monitors the products in the market whenever the manufacturer founds any product defective or potential harmful they would recall it or sometime FDA recalled the product after customer complaints. There can be number of reasons like health…   Read more»

]]> d35d30045f04ee4b21a685386cd7e45f https://medicaldevicecourses.com/activity/p/18280/ Wed, 15 May 2019 21:46:55 -0400 I would like to be a statistician . Clinical projects usually collects a lots of data so the statistician summarize the data so that non statistician can understand. A Statistician helps to optimize design, analysis, interpretation of results and conclusion….   Read more»

]]> c87151d0cb500911490247d51c3189e8 https://medicaldevicecourses.com/activity/p/18240/ Wed, 15 May 2019 21:46:36 -0400 When considering a clinical trial budget, it is important to consider following factors like to determine full cost of study do not depend solely on protocol’ study flow chart .other costs should be considered like cost related with shipping. Always…   Read more»

]]> e400da209136161db5dd0ba79694b0ba https://medicaldevicecourses.com/activity/p/18239/ Wed, 15 May 2019 21:46:36 -0400 When considering a clinical trial budget, it is important to consider following factors like to determine full cost of study do not depend solely on protocol’ study flow chart .other costs should be considered like cost related with shipping. Always…   Read more»

]]> 54f986463285806cf1f71bc425e68002 https://medicaldevicecourses.com/activity/p/18226/ Wed, 15 May 2019 21:46:30 -0400 The project manager for medical device company leads the team of engineer ,owns the relationship with clients and applying engineering knowledge to ensure successful outcomes . Assembling a medication reconciliation team is an important task for project manager for medical…   Read more»

]]> 7c4d89f575d374174fd21f878d94a43f https://medicaldevicecourses.com/activity/p/18225/ Wed, 15 May 2019 21:46:29 -0400 The Non-Conformance Material Report is used to report and disposition non-conforming material identified during inspection (Quality or Warehouse Inspection) or during the movement of the materials and/or when the material is in stock. The material is inspected to verify that…   Read more»

]]> ad51cc0c274eaa9b14f909b7ae0ac62e https://medicaldevicecourses.com/activity/p/18172/ Wed, 15 May 2019 21:46:00 -0400 Contract negotiation should be based on the uncertainty of scope, assignment of risks, need for predictable costs and importance of meeting milestones dates. Contract should be fair ,reasonable , and beneficial to both parties not depends upon the smart party….   Read more»

]]> 7c507837824f097380993d10fdfa7bfa https://medicaldevicecourses.com/activity/p/18162/ Wed, 15 May 2019 21:45:55 -0400 Six Sigma uses statistical and numeric methods to reduce the number of defects in output to an insignificant level. It focus on understanding customer’s requirement better and eliminating waste and defects. The objectives is to improve the organization’s products, services,…   Read more»

]]> db40d670a3facc161fa20dabb6d61d44 https://medicaldevicecourses.com/activity/p/18160/ Wed, 15 May 2019 21:45:53 -0400 The QA and QC both are the part of Quality Management system .QMS takes comprehensive approach affecting the company’s processes ensuring the safety and efficiency. QA is process oriented or procedure oriented as it focused on methods how to prevent…   Read more»

]]> ffecba708169eb6c832ef9d77338e8aa https://medicaldevicecourses.com/activity/p/18110/ Wed, 15 May 2019 21:45:29 -0400 SV and CV are two essential parameter in earned value management and helps to analyze the project. If both are positive means project is progressing well but if one of the variance is negative then some corrective action are needed…   Read more»

]]> fb91a8b92727680dcb926f0da9d5c48f https://medicaldevicecourses.com/activity/p/18101/ Wed, 15 May 2019 21:45:25 -0400 A significant mistake in project planning is to assume full availability of all the team members. The management has the right to rearrange the employee vacation schedule to meet the deadlines. in the absence of a team member the project…   Read more»

]]> 5a53bee4ca31f06a19c659f6510cef7c https://medicaldevicecourses.com/activity/p/18100/ Wed, 15 May 2019 21:45:24 -0400 The process of identification and evaluating risks starts in the planning phase of the project and continues through out the project. It is important to determine each risk likelihood to occurring as well as its effect on the overall project…   Read more»

]]> 8667d1bed267bc4b9290c82c3e447507 https://medicaldevicecourses.com/activity/p/18033/ Wed, 15 May 2019 21:44:50 -0400 Risk is when an uncertain event or condition can occur and have an effect on the project outcome. Project manager tries to know everything about risks so that it could not effect negatively to the project. Project managers know how to…   Read more»

]]> d666cacaa5dd430670e2d0bae799f137 https://medicaldevicecourses.com/activity/p/18023/ Wed, 15 May 2019 21:44:42 -0400 For any medical device manufacturer an FDA audit is a necessary and a potentially difficult part. The company should maintains proper documentation . The updated documents like DHF,DMR and dozens of other demonstrates the commitment to quality , accuracy and…   Read more»

]]> e374bfaf84554273c10bc7c982a74d5f https://medicaldevicecourses.com/activity/p/18022/ Wed, 15 May 2019 21:44:41 -0400 Design verification is important for ensuring the success of a medical device. It demonstrates that the product is safe ,designed correctly and design input meets design output. Design verification should start at an early stage when design input are developed….   Read more»

]]> a515a5fe0d8e26fc1e8703eed8276ea4 https://medicaldevicecourses.com/activity/p/17956/ Wed, 15 May 2019 21:44:09 -0400 The project closing phase is as significant and impactful as the Initiation, Planning, Executing, and Monitoring and Controlling phase. The impact of project closing can be extensive, both to the project and to the organization. The key benefits of this…   Read more»

]]> a48a0cafb53a76563c57796e71cfe27f https://medicaldevicecourses.com/activity/p/17948/ Wed, 15 May 2019 21:44:05 -0400 A risk management team is a separate and often independent unit within the project management team headed by the risk manager .The team also develops strategies to mitigate identified risks, applies risk management methodologies and risk analysis tools, and integrates…   Read more»

]]> 1105fad1feb452fdc9e4f8b33a466e99 https://medicaldevicecourses.com/activity/p/17932/ Wed, 15 May 2019 21:43:57 -0400 The Planning/Initiation phase sets the foundation for the other phases. The execution phase is also an important part of project . Being the longest phase of project because there are three primary steps include building the deliverables, monitor and control,…   Read more»

]]> 87c4a5d32172f00e5c8e35ff3a1eddb1 https://medicaldevicecourses.com/activity/p/17884/ Wed, 15 May 2019 21:43:33 -0400 The unresponsive team member’s communication delays the entire project or causes the organization to miss opportunities. Decisions may be delayed and delayed meetings disrupt project schedules . However chasing people for responses distracts people from more productive work. In case…   Read more»

]]> 76b8467ab966a29a38356bf020384d0e https://medicaldevicecourses.com/activity/p/17865/ Wed, 15 May 2019 21:43:23 -0400 One of the challenge that the project manager can face is enabling leadership in other. Team members are more calm and focused when they are in charge of their own work and not under the constantly evaluative eye of a…   Read more»

]]> c77b60b2422ba9cfeba447f0f1a2854f https://medicaldevicecourses.com/activity/p/17854/ Wed, 15 May 2019 21:43:17 -0400 Accurate time estimation is essential for a good project management. Sometimes project manager fails to estimate correct time due to unexpected events or unscheduled high priority works or may be unfamiliar with the type of task . For estimating correct…   Read more»

]]> 53d5d5115ef27e28ad78172d35c32645 https://medicaldevicecourses.com/activity/p/17823/ Wed, 15 May 2019 21:42:56 -0400 Missing a milestone leads to failure of a project. Milestones can be used to determine the success of your project and super effective way to manage multiple projects at the same time effectively. All milestones should be specific and measurable…   Read more»

]]> 90202437a8aed25cf84b2797af0e9646 https://medicaldevicecourses.com/activity/p/17812/ Wed, 15 May 2019 21:42:51 -0400 There are various success factors for a project like smart people in the team,smart planning, careful risk management,clearly defined plans and open communication . Clear planning is an important part of project success . All projects must have a plan…   Read more»

]]> 057a53d998ac90e62bc8bedd63d6877d https://medicaldevicecourses.com/activity/p/17807/ Wed, 15 May 2019 21:42:48 -0400 Design Validation is a Design Controls activity that happens late in the product development .This is the stage where you actually build a version of the product and validate against the user requirements. The process of validation generally occurs as…   Read more»

]]> 69a8e6173d109de46c2d8b0ffb6aad48 https://medicaldevicecourses.com/activity/p/17805/ Wed, 15 May 2019 21:42:47 -0400 Risk is the function of seriousness of the harm and probability that will occur . The risk can be physical,social,physiocologlcal, Economic. The risk-benefit ratio is a comparison between the risks of a situation and its benefits. The goal is to…   Read more»

]]> f1c82bdfb05ef74c0bbecf4742a11fb2 https://medicaldevicecourses.com/activity/p/17728/ Wed, 15 May 2019 21:42:08 -0400 Combination products are assigned to Centers with primary jurisdiction for premarket reviews and regulation. The determination is based on “primary mode of action” of the combination product. Sponsors can determine their product’s PMOA, If the PMOA is unclear, a sponsor…   Read more»

]]> 70600ad48d49ddc25d8af6b0ac0368df https://medicaldevicecourses.com/activity/p/17726/ Wed, 15 May 2019 21:42:07 -0400 Design transfer is a complex process involves transfer an approved design into production. Every manufacturer should follow procedure to ensure that design is correctly transfer into production specification. Sometime the product team doesn’t understand or don’t have enough time to…   Read more»

]]> f7ef5444b157e27512a2e91536a7956e https://medicaldevicecourses.com/activity/p/17721/ Wed, 15 May 2019 21:42:05 -0400 Change control is a procedure for ensuring that changes to any product within scope of quality management system are planned, approved and implemented in a controlled manner maintaining safety and efficacy of the product. The company have to decide they…   Read more»

]]> 9f6fb2181579a3f9627e87828f3b45d8 https://medicaldevicecourses.com/activity/p/17691/ Wed, 15 May 2019 21:41:49 -0400 The project manager is mainly involved in the early stage of a project and ensuring that the company have a clear understanding of client’s goals and desires outcomes. Project manager has to perform the task related to timelines, budget ,…   Read more»

]]> ae10b7c56bd83d6761b913d7a9bae7ab https://medicaldevicecourses.com/activity/p/17630/ Wed, 15 May 2019 21:41:16 -0400 The matrix structure allows an efficient use of company’s resources. There could be some negative impact on project due to conflict between project manager and functional manager. The most difficult challenge in matrix form is team development. Every member in…   Read more»

]]> 7b79caa4ed9047fb8eb9fdd7ca22570e https://medicaldevicecourses.com/activity/p/17629/ Wed, 15 May 2019 21:41:16 -0400 The different stages of project includes initiation, planning ,execution ,managing and control , closing. In the initiation phase of a project ,the project meeting are quite important which states the roles and responsibilities of individual working on the project it…   Read more»

]]> 73a7fedd24aaa1e92c88aa13827a9d8b https://medicaldevicecourses.com/activity/p/17550/ Wed, 15 May 2019 21:40:31 -0400 Interpersonal skills are as important as technical knowledge .Interpersonal skills are the way to how someone relate and communicate with other. Interpersonal skills are attributes that are used to motivates employees and how to make them use their knowledge to…   Read more»

]]> e6b2423fdf9764cc51eca1ec125ff0eb https://medicaldevicecourses.com/activity/p/17544/ Wed, 15 May 2019 21:40:26 -0400 The risk management plan is a document prepared by project manager to foresee risks and methods to either minimize or eliminate their negative impact on project . An ideal risk management plan can solve any unexpected problem coming while executing…   Read more»

]]> 28025d04998932e25e352b97fc88d3df https://medicaldevicecourses.com/activity/p/17540/ Wed, 15 May 2019 21:40:24 -0400 When bringing a medical device into market company will determine whether to submit 510(K) or PMA. If the company could not make right decision getting unsafe product in customer’s hands causes serious damage and product failure. The class II devices…   Read more»

]]> 1ee4581fd4964177d103bec52375b56c https://medicaldevicecourses.com/activity/p/17511/ Wed, 15 May 2019 21:40:08 -0400 The company should invest in the project if it is making steps in right direction. Not every idea has the potential to turn into a viable business. Great idea needs to solve specific kind of a problem in order to…   Read more»

]]> de3b31c29161c4c9360ebff5a17fed8a https://medicaldevicecourses.com/activity/p/17507/ Wed, 15 May 2019 21:40:06 -0400 The efficiency and outcomes of a project directly depends on the team who work on the project. However assembling right people for team is a critical task. For a successful project, the requirement of a project should be deeply understand…   Read more»

]]> 7e68ef2c0331d55b0644e4e71353034e https://medicaldevicecourses.com/activity/p/17501/ Wed, 15 May 2019 21:40:03 -0400 A Quality Plan clearly defines what the quality management system is supposed to achieve. Quality planning means that you are going to make a device according to the project plan . Beside the project is completed on time and in…   Read more»

]]> 9bb9c664e9a299c33b9d7b2e520b0e07 https://medicaldevicecourses.com/activity/p/17430/ Wed, 15 May 2019 21:39:27 -0400 The project manager for medical device company leads the team of engineer ,owns the relationship with clients and applying engineering knowledge to ensure successful outcomes . Assembling a medication reconciliation team is an important task for project manager for medical…   Read more»

]]> bb37e76f48c56f0c70f4d59f0b5f0f2f https://medicaldevicecourses.com/activity/p/17429/ Wed, 15 May 2019 21:39:27 -0400 When a physician uses unapproved medical devices it risks the safety and health of patients. Such medical devices should not be available during regular clinical care. FDA recognizes the emergency use of a investigational devices in a immediate life threating…   Read more»

]]> d7a9aaba4a97a0bd8a2f39ab34b779fc https://medicaldevicecourses.com/activity/p/17428/ Wed, 15 May 2019 21:39:26 -0400 Labeling and packaging of product pay a great deal of attention to ensuring compliant with good manufacturing practices (GMPs) and FDA regulations. The manufacturers can’t afford to ignore errors in product labeling or packaging artwork or missing information. Mislabeling can…   Read more»

]]> e86ce8a18ad69eb1aa52302c4993a4c2 https://medicaldevicecourses.com/activity/p/17369/ Wed, 15 May 2019 21:38:54 -0400 Stark law, is a complex set of regulations that has constantly expanded since its initial publication in 1995. Stark law restricts the physician from self referral patient to a designated place where he or his family members has a financial…   Read more»

]]> 2e3cbe14269d77e705166f0a865e1d37 https://medicaldevicecourses.com/activity/p/17332/ Wed, 15 May 2019 21:38:37 -0400 The gift triggers a human instinct to reciprocate; even if the reciprocation involves nothing more than giving the detail person a few moments of your time.  It may be entirely reasonable to accept a small token of appreciation from a…   Read more»

]]> 8559fec3aadc2451021386b9c853c3d2 https://medicaldevicecourses.com/activity/p/17329/ Wed, 15 May 2019 21:38:35 -0400 Danvers-based Abiomed, Inc. has agreed to pay $3.1 million to resolve allegations that it violated the False Claims Act by purchasing lavish meals for physicians in order to induce them to use Abiomed’s Impella line of heart pumps.  The United States contends that Abiomed sought to induce physicians to use its pumps,…   Read more»

]]> 26a4515cc1cf34205fe444adfdd6c6d2 https://medicaldevicecourses.com/activity/p/17287/ Wed, 15 May 2019 21:38:15 -0400 The matrix structure allows an efficient use of company’s resources. There could be some negative impact on project due to conflict between project manager and functional manager. The most difficult challenge in matrix form is team development. Every member in…   Read more»

]]> e9e51f51c4ab2ce5258ba997e3acf239 https://medicaldevicecourses.com/activity/p/17260/ Wed, 15 May 2019 21:38:01 -0400 The culture and structure of an organization can influence the way projects are managed and executed. If the organization follows a good, project management process, then chances of success of project increases . The project team member should know the…   Read more»

]]> 0cf9e6c4d413cb823fa78e3cc3af732f https://medicaldevicecourses.com/activity/p/17242/ Wed, 15 May 2019 21:37:53 -0400 The reason for choosing the matrix in an organization is that functions and skills are fragmented throughout the organizational structure. Individual functional departments may face difficulties in solving very large problems because of a failure to view the total system…   Read more»

]]> e93c2d5d6857e37e1c57f0f82e626db3 https://medicaldevicecourses.com/activity/p/17189/ Wed, 15 May 2019 21:37:23 -0400 ALAPRP is ‘as low as reasonably practicable’. It requires weighing the risk against the time,cost needed to control it. Deciding whether the risk is ALARP is quite challenging because it requires the duty holder to exercise judgement. In a complex…   Read more»

]]> b0e49b42cfd14c1e6f79e0cf7a181532 https://medicaldevicecourses.com/activity/p/17129/ Wed, 15 May 2019 21:36:53 -0400 The key to a successful risk assessment meeting is to be sure that the Risk Assessment Meeting includes Key Project Team Members and Key Stakeholders. By conducting a risk assessment meeting the Project Manager will be able to identify the…   Read more»

]]> 41dd69348bfe590ad1198357f941962d https://medicaldevicecourses.com/activity/p/17126/ Wed, 15 May 2019 21:36:51 -0400 Risk analysis is a tool to evaluating any risk or incident that can happen to the patients who are using medical devices. Risk identification is the important part the sooner, the risk are identified ,sooner methods or plans can be…   Read more»

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