https://medicaldevicecourses.com/members/sam-doksh/activity/ Activity feed for Sam Doksh. Fri, 24 Apr 2026 23:46:26 -0400 https://buddypress.org/?v= en-US 30 hourly 2 680e10a1a7d3fcce0b3a971032843350 https://medicaldevicecourses.com/activity/p/19985/ Mon, 27 Apr 2020 22:16:51 -0400 In project  ” size ” is an all encompassing designation, used to quantify the overall “extent” of the project effort, usually accounting for duration, cost, complexity, staffing requirements and related parameters. This allows projects to be characterizes in comparative terms…   Read more»

]]> 7007e8a0cf2d040a91c2eedebe4148a9 https://medicaldevicecourses.com/activity/p/19984/ Mon, 27 Apr 2020 22:02:20 -0400 The idea of sponsorship is to develop strong relationships between the business and its customers due to their common ties with the sponsored individual , event, or the organization. Sponsorship provides a great means of broadening your competitive edge by…   Read more»

]]> 6a0af2bee854b7efabf15ae6ede62797 https://medicaldevicecourses.com/activity/p/19983/ Mon, 27 Apr 2020 21:50:47 -0400 Building strong vender relationships communicate. The first step to nurturing an effective business relationship is by establishing and maintain a connection. Explain your business goals: Its critical at the start of any vendor relationship to communicate your goals, business vision,…   Read more»

]]> a22092a5051f48ed4d1698a01f0d83cd https://medicaldevicecourses.com/activity/p/19982/ Mon, 27 Apr 2020 21:36:10 -0400 Managers develop plans and schedules for reaching technical goals, such as new product development. Engineers focus on the job at hand, the focus of managers is on the team they are given to accomplish a task… An engineer relies on…   Read more»

]]> 3cb57df3a55e72d0af362858fd1ca679 https://medicaldevicecourses.com/activity/p/19971/ Mon, 27 Apr 2020 02:24:09 -0400 Motivator: A person who shares his words of motivation with others. anyone who motivates or stimulates others to take action or to realize a dream. Meeting deadlines, targets, or goals. mentoring and coaching others. learning new things. coming up with…   Read more»

]]> 380088532c8b10f8dcce4d6d2bb81ede https://medicaldevicecourses.com/activity/p/19924/ Mon, 20 Apr 2020 21:28:26 -0400 Employee retention refers to the ability of an organization to retain its employees .. In a business setting, the goal of employers is usually to decrease employee turnover, thereby decreasing training costs, recruitment costs and loss of talent and organizational…   Read more»

]]> f19912e0a64003ba603662d20d84fb19 https://medicaldevicecourses.com/activity/p/19923/ Mon, 20 Apr 2020 21:11:43 -0400 The official definition- Non- Conformance Material Report(NCMR) is a standard way to report non-conforming material that is identified during inspection of times or material, or during the movement of the materials when the materials is in stock. These are products…   Read more»

]]> 1e1f3a3c577cd3f101a013249e4b3bea https://medicaldevicecourses.com/activity/p/19922/ Mon, 20 Apr 2020 21:01:29 -0400 A good manager achieves a hard working, productive and effective workforce that punches above its weight in its performance. Good managers attract exceptional staff; they make the organization a preferred employer; they help to increase market share. There are guide…   Read more»

]]> d240cf15b4f5cdefca22d62c06bc48ec https://medicaldevicecourses.com/activity/p/19899/ Sun, 19 Apr 2020 23:36:44 -0400 First off, change within the context of project management is anything that transforms or impacts projects , tasks, processes, structures, or even job functions. Therefore change management refers to the tools and processes you use to manage change within a…   Read more»

]]> c3b7dd88b778e7f774be8a694a66c775 https://medicaldevicecourses.com/activity/p/19865/ Wed, 15 Apr 2020 01:26:27 -0400 Project integration management is the coordination of all elements of a project. This includes coordinating tasks, resources, stakeholder, and any other project elements. Integrated project management is the collection of processes that ensure various elements of projects are properly coordinated….   Read more»

]]> b61ed2058fe6eccbaa94f0faa19c4a32 https://medicaldevicecourses.com/activity/p/19858/ Mon, 13 Apr 2020 20:31:58 -0400 QA&QC both are different from each other and required as part of quality management … QA is process focused while QC is end product focused. Quality Control is inspecting something( a product or a service) to ensure that it is…   Read more»

]]> c84c73ced93f7fb217e599c51ee43cd9 https://medicaldevicecourses.com/activity/p/19857/ Mon, 13 Apr 2020 20:14:25 -0400 Procurement management is the strategic approach to managing and optimizing organizational spend. it involves acquiring quality goods and services from preferred vendors within a stipulated budget. Procurement management is the process of ensure that everything required from outside the organization…   Read more»

]]> 4f158d1e474f332fdb09f12786710c3a https://medicaldevicecourses.com/activity/p/19856/ Mon, 13 Apr 2020 19:48:38 -0400 Human Resource Management deals with issues related to compensation, performance management, organization development, safety, wellness, benefits, employee motivation and training. The human resource department is important because they are the ones that keep employees grounded by maintaining employee satisfaction. Human…   Read more»

]]> 00362b6d94d27ceff8339471568d634e https://medicaldevicecourses.com/activity/p/19806/ Mon, 06 Apr 2020 15:15:16 -0400 Combination products: The term combination product includes: 1- A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic.  2- Two or more separate products packaged together in a single package. 3- A drug, device, or…   Read more»

]]> aa62e3c270fe93ab0268eccc5901a797 https://medicaldevicecourses.com/activity/p/19805/ Mon, 06 Apr 2020 14:55:58 -0400 Project changes, change within the context of project management is anything that transforms or impacts projects, tasks, processes, structures, or even job function. Therefore change management refers to the tools and processes you use to manage change within a project…   Read more»

]]> a72b5cce749afe9e8650f8809ed2a595 https://medicaldevicecourses.com/activity/p/19804/ Mon, 06 Apr 2020 14:39:54 -0400 A project manager, together with the team will face any issues during the project process cycle, There are steps to face the issues: – Accept that there is a conflict.   – Create an environment conducive to cooperation.  – Understand…   Read more»

]]> 69e28324e584103eb674153f938c5f0b https://medicaldevicecourses.com/activity/p/19759/ Wed, 25 Mar 2020 23:28:14 -0400 Validation is the process of making sure that you have objective evidence that user needs and intended uses are met.. Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm…   Read more»

]]> 8dafc7d7c66cba2ed2e63e4a76705c9e https://medicaldevicecourses.com/activity/p/19758/ Wed, 25 Mar 2020 22:35:17 -0400 Design Transfer is best defined as the processes procedures, and related tasks implemented during medical device design and development to ensure that the device design is correctly translated into production specifications and that the design outputs are verified as suitable….   Read more»

]]> e8766c1674743da924cee08c0efcf797 https://medicaldevicecourses.com/activity/p/19750/ Mon, 23 Mar 2020 14:50:09 -0400 Meeting a deadline means that you were successful in fulfilling your task before it was too late. There are essential tips for meeting a deadline: 1- Care about deadlines, This is the first step, as many people are very lax…   Read more»

]]> 0015d06a6b3d1f14204f6e002c06536b https://medicaldevicecourses.com/activity/p/19749/ Mon, 23 Mar 2020 14:38:17 -0400 Changing control in project management ensure that each change proposed during a project is adequately defined, reviewed and approved before implementation. The change control process helps avoid unnecessary changes that might disrupt services and also ensures the efficient use of…   Read more»

]]> 0a18f35203f51fdaa11cd103866875be https://medicaldevicecourses.com/activity/p/19748/ Mon, 23 Mar 2020 14:28:14 -0400 The monitoring and control process of the project management consists of the activities involved to observe the process after project implementation, identify problems and risk, and deploy a mitigation strategy to control the new process. Monitoring and Controlling project work…   Read more»

]]> a592500514a44b24886d3cacd60224c4 https://medicaldevicecourses.com/activity/p/19691/ Tue, 10 Mar 2020 14:56:53 -0400 Metrics permit organizations to measure its performance against industry sectors to determine how well the company is doing. Metrics help transform the vague requirements that a customer gives into a series of numbers that can be used to accurately map…   Read more»

]]> e9d3339b3487ed067b263af0b7e49c67 https://medicaldevicecourses.com/activity/p/19690/ Tue, 10 Mar 2020 14:40:43 -0400 Combination products are medical products that combine a drug, device and/or biological product. in order to ensure efficient review, a single application is generally appropriate for combination products. FDA provides a structured framework for evaluating combination products, considering both device…   Read more»

]]> 4cfc5551210a0d098bfdd814da593597 https://medicaldevicecourses.com/activity/p/19689/ Tue, 10 Mar 2020 14:27:21 -0400 The executing process refers to any specific point during the activity or project as a whole in which  the act of executing takes place, and the predetermined processes of getting to that point of accomplishing that action successfully. Project execution…   Read more»

]]> 5e386eab7945e8bc4ded75d7130c8701 https://medicaldevicecourses.com/activity/p/19666/ Sun, 08 Mar 2020 03:05:04 -0400 Scope management is the process of defining what work is required and then making sure all of that work. scope management plan should include the detailed process of scope determination, its management, and its control. In project management, scope is…   Read more»

]]> dad1df5f09ef1df6d3248ae6c5c467ef https://medicaldevicecourses.com/activity/p/19665/ Sun, 08 Mar 2020 03:42:21 -0400 A risk management team is a separate and often independent unit within the project management team headed by the risk manager or the chief risk officer. It helps place a value on the projects activities . The  role of a…   Read more»

]]> b5db395cd53d59c9141782831f3d5ce1 https://medicaldevicecourses.com/activity/p/19638/ Mon, 02 Mar 2020 17:04:44 -0500 The purpose of customer input is to translate the customer requirements. Customer inputs is usually garnered via surveys and complaints. Customer involvement entails engaging customer in a two- way iterative conversation using a variety of mediums including focus group, surveys,…   Read more»

]]> ff80f8d0cf015584ab44d8e93e8569b0 https://medicaldevicecourses.com/activity/p/19637/ Mon, 02 Mar 2020 16:50:33 -0500 Preplanning is the review of planned operations before and during construction in order to identify and eliminate potential loss. The goal of preplanning is to reduce hazards, which will minimize disruption, increase efficiency, and lower costs. Pre-operational safety planning involves…   Read more»

]]> 50d93e66ddcff36bc16e36ee0def7760 https://medicaldevicecourses.com/activity/p/19636/ Mon, 02 Mar 2020 16:35:05 -0500 Successful team development involves great leadership and support at every stage of the process. It is important for team leaders to facilitate the introductions and highlight each persons skills and background. Team member are also given project details and the…   Read more»

]]> 1a2eaf1c9748b7473a0cb8294ea0e5e4 https://medicaldevicecourses.com/activity/p/19593/ Wed, 26 Feb 2020 18:08:17 -0500 There are lots of project management success factors that play a role in a project successful. A project manager should endeavor to elicit commitment from the team members, clients, top management and all stakeholders. A project management should ensure that…   Read more»

]]> f4bb26148b241fdf3facdeab81239d8c https://medicaldevicecourses.com/activity/p/19592/ Wed, 26 Feb 2020 17:55:06 -0500 Design change request is a formal proposal for an alteration to some product or system. In project management, a change request often arises when the client wants an addition or alteration to the agreed upon deliverables for a project. The…   Read more»

]]> 05447b7a1b98248b26b41ac23929bb32 https://medicaldevicecourses.com/activity/p/19585/ Mon, 24 Feb 2020 17:26:16 -0500 Project execution is the phase in which the plan designed in the prior phases of the project life cycle is put into action. The purpose of project execution is to deliver the project expected results. Is to develop and produce…   Read more»

]]> 13dd4a437621337bf9db909856806123 https://medicaldevicecourses.com/activity/p/19584/ Mon, 24 Feb 2020 17:02:49 -0500 The closing phase of project management is the final phase of the project lifecycle. This is the stage where all deliverables are finalized and formally transferred, and all document is signed off, approved, and archived. The primary objective of the…   Read more»

]]> 4d2405ec0e14f477bc7527380e50f5fb https://medicaldevicecourses.com/activity/p/19583/ Mon, 24 Feb 2020 16:27:02 -0500 A Gantt chart is a type of bar chart that illustrates a project schedule. This chart list the tasks to be performed on the vertical axis, and time intervals on the horizontal axis. Gantt charts are usually created initially using…   Read more»

]]> 941217855c511b9c8f622aeeca5f8b54 https://medicaldevicecourses.com/activity/p/19532/ Fri, 21 Feb 2020 15:47:43 -0500  Design validation is one of the most important aspects of the design and development process for medical devices. Design Validation is a testing process by which you prove validate that the device works for the end user as intended. official…   Read more»

]]> 7d76e1a4bbdf3b55c87763f71ad49861 https://medicaldevicecourses.com/activity/p/19531/ Fri, 21 Feb 2020 15:37:29 -0500 Risk management involves the identification, understand, control, and prevent failures that can result in hazards when people use medical devices. Risk analysis plays a key role in the development of medical devices. Risk management is necessary to ensure device usability,…   Read more»

]]> 37e1f35d4923e766f2ea7f5b9389edc9 https://medicaldevicecourses.com/activity/p/19522/ Mon, 17 Feb 2020 17:23:54 -0500 The planning phase is when the project plans are documented, the project deliverables and requirements are defined, and the project schedule is created. It involves creating a set of plans to help the project team through the implementation and closure…   Read more»

]]> 60aecada41aee967e046e550ab0f5009 https://medicaldevicecourses.com/activity/p/19521/ Mon, 17 Feb 2020 17:09:11 -0500 Monitoring is checking the progress of the project to ensure compliance with project scope, timelines, deliverables and schedules. Project control is measuring such progress by comparing and contrasting actual progress with project plans and schedules and taking corrective action as…   Read more»

]]> 5d9f45cddd5aaa839574cd1dbf3a3a3b https://medicaldevicecourses.com/activity/p/19520/ Mon, 17 Feb 2020 16:55:13 -0500 A risk management team is a separate and often independent unit within the project management team headed by the risk manager or the chief risk officer. The role of a risk manager is to communicate risk policies and processes for…   Read more»

]]> a045e63b19957be2eefd825f1d7756b8 https://medicaldevicecourses.com/activity/p/19481/ Thu, 13 Feb 2020 16:41:31 -0500 One of the most important aspects of a project manager job is measuring progress of the project on each task. It helps employees stay focused. There are some steps that help to measure project progress:  – Tracking tasks   -…   Read more»

]]> b7891b6a2b2ed8084f32aafd722aea71 https://medicaldevicecourses.com/activity/p/19454/ Mon, 10 Feb 2020 16:15:00 -0500 Medical device simulation has been found to enhance clinical competence, It has also been found to have many advantages that can improve patient safety and reduce health care costs through the improvement the medical provider competencies. Simulation modeling solves real…   Read more»

]]> 429aa9fc4439af09ec251acebc8fb3ab https://medicaldevicecourses.com/activity/p/19453/ Mon, 10 Feb 2020 15:51:16 -0500 Validation should take place from the early to the final stage of our product lifecycle and even after the release to the final solution. Verification and Validation are independent procedures that are used together for checking the project. Verification is…   Read more»

]]> 7856665df60e7f14b897554078be0a94 https://medicaldevicecourses.com/activity/p/19452/ Mon, 10 Feb 2020 15:25:10 -0500 It is critical to understand the important of project initiation phase and how to initiate projects successfully. The project initiation phase is arguably the most important step for enabling success. There are some steps to initiate the projects quickly and…   Read more»

]]> 6106a83e0095e9d99f946bc02c59acde https://medicaldevicecourses.com/activity/p/19435/ Sun, 09 Feb 2020 21:37:58 -0500 Verification and validation  are  independent procedures that are used together for checking that a product, service, or system meets requirements  and specifications.  Validation : The assurance that a  product service, or system meets the needs of the customer and other…   Read more»

]]> c1f734309e7b2914fbae34beec90871e https://medicaldevicecourses.com/activity/p/19392/ Wed, 05 Feb 2020 16:27:06 -0500 The project initiation phase is the 1st phase in the project life cycle. It is at this point where the opportunity or reason for the project is identified and a project is developed to take advantage of that opportunity. as…   Read more»

]]> 4172eabc6b3e062a44e79afe59f8561c https://medicaldevicecourses.com/activity/p/19391/ Wed, 05 Feb 2020 16:03:16 -0500 FDA has required that medical device that want to market certain categories of medical devices in the UISA follow Design Control requirements.Design and development planning  . Design input, including intended use and user needs.Design output: including evaluation of conformance to…   Read more»

]]> 79c3346a3048258dc1c0e59f64d36040 https://medicaldevicecourses.com/activity/p/19390/ Wed, 05 Feb 2020 15:45:10 -0500 Product life cycle management is the succession of strategies by business management as a product goes through its life cycle. The life cycle of a product is associated with marketing and management decisions within business. The concept of product life…   Read more»

]]> 422cd6df8a8300af4b0d07e12ab62282 https://medicaldevicecourses.com/activity/p/19337/ Thu, 30 Jan 2020 15:31:20 -0500 FDA legal authority to regulate both medical devices and electronic radiation- emitting products in the federal Food Drug& Cosmetic Act. To fulfill the provision of the FD&C Act that apply to medical devices and radiation – emitting products, FDA develops,…   Read more»

]]> 905d7e1ba94011141158e539814460ee https://medicaldevicecourses.com/activity/p/19336/ Thu, 30 Jan 2020 15:19:11 -0500 Mistakes happen, How a team deals with and learn from them is what determines if the team will eventually become a winning team. There are some common project management mistakes and how to avoid them: – Assigning the wrong person…   Read more»

]]> a5a4b71c18fecbb61dc62fa8ec378851 https://medicaldevicecourses.com/activity/p/19332/ Wed, 29 Jan 2020 15:30:49 -0500 The main objective of the priority Medical Device project was to identify gaps in the availability of preventive, diagnostic, therapeutic and assistive medical devices on the market. Mapping of gaps in the supply of medical devices constitutes a priority of…   Read more»

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