Medical Device Courses | Aasutosh Purohit | Activity https://medicaldevicecourses.com/members/aasutosh-purohit/activity/ Activity feed for Aasutosh Purohit. Fri, 24 Apr 2026 17:22:27 -0400 https://buddypress.org/?v= en-US 30 hourly 2 f33267d452c615d7e31092efd8d77e69 Aasutosh Purohit replied to the topic "What it an NCMR" - https://medicaldevicecourses.com/activity/p/16005/ Wed, 15 May 2019 19:16:05 -0400 Any item, part or product with one or more characteristics which depart from the requirements of the specification, safety, legality, regularity & quality or other approved product description. Nonconformity refers to a failure to comply with the requirement.A requirement is…   Read more»

]]> c68c5154f09373cd15c49acdc2e96677 Aasutosh Purohit replied to the topic "Engineer vs. Manager" - https://medicaldevicecourses.com/activity/p/15886/ Wed, 15 May 2019 19:14:58 -0400 For me, I will work as an engineer for 3-4 years and learn most of the technical stuff that I can use to enhance my career so that i have a proper experience and then I will shift to management…   Read more»

]]> fb7c96084d0075d8e04e441e52e8fdd6 Aasutosh Purohit replied to the topic "Factors to look for while preparing schedule and budget for Clinical Trial" - https://medicaldevicecourses.com/activity/p/15881/ Wed, 15 May 2019 19:14:55 -0400 There are many factors to look for while preparing schedule and budget for clinical trials. 1. Start-Up Fees: This Start-Up Fee includes all of the Internal Committee and IRB application preparations, budget negotiations, regulatory document preparation as well as on-site…   Read more»

]]> 09098c0aa4f4ed8dd94d2d4ecbbab73e Aasutosh Purohit replied to the topic "Analogous vs Bottom Up Cost Estimating" - https://medicaldevicecourses.com/activity/p/15771/ Wed, 15 May 2019 19:13:44 -0400 Analogous Estimating: This technique is used to estimate the project cost when very little detail about the project is available. Therefore, this technique does not provide a very reliable estimation. The primary benefits of this technique are its lower cost…   Read more»

]]> fbe8e669b3c7343becdc406234bac64c Aasutosh Purohit replied to the topic "Things to look for in a contract while selecting a supplier" - https://medicaldevicecourses.com/activity/p/15769/ Wed, 15 May 2019 19:13:43 -0400 Choosing the right supplier involves much more than scanning a series of price lists. The choice will depend on a wide range of factors such as value for money, quality, reliability and services. A key criterion in selecting the right…   Read more»

]]> f94574b724ee85eee30be9594535a16b Aasutosh Purohit replied to the topic "how the PM handles budget cut?" - https://medicaldevicecourses.com/activity/p/15627/ Wed, 15 May 2019 19:12:16 -0400 It’s a matter of Change of Management on the project, and as such should be already part of the project plan in the first place. Every project will face issues of one kind or another, and project plan should provide…   Read more»

]]> 2d37ebc7f5bcc175a2f68c3bb9c6b12d Aasutosh Purohit replied to the topic "Things help to understand project status other than project matrix" - https://medicaldevicecourses.com/activity/p/15605/ Wed, 15 May 2019 19:08:09 -0400 Factors other than matrix that can help detect the status of the project and help us have a rough estimate of time frame for the project depends on how well we manage these factors: -Integration – Scope – Time/schedule -…   Read more»

]]> 4f059cbc5bf8131c435e312ce60c0e46 Aasutosh Purohit replied to the topic "Importance of Metrics" - https://medicaldevicecourses.com/activity/p/15538/ Wed, 15 May 2019 19:07:24 -0400 Different project management metrics can be defined based on a project’s objective and complexity. However, the following five typically cover the most important measurements: Productivity – This metric allows project managers to assess the utilization of resources. It compares the…   Read more»

]]> 9a8842ea0fbf3005a044602da25bdb4b Aasutosh Purohit replied to the topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/15511/ Wed, 15 May 2019 19:07:09 -0400 In my point of view some important aspects for consideration during design transfer and handing off the product are: Safety: The risk to humans or the environment Accuracy: The difference between the expected truth and the actual parameter Precision: The…   Read more»

]]> 6ab87f7f9e1b1a62ee97a8f82690873b Aasutosh Purohit replied to the topic "Project Execution" - https://medicaldevicecourses.com/activity/p/15418/ Wed, 15 May 2019 19:06:06 -0400 Commitment to Customer: It is essential that the manager sensitizes the team that release plans once locked-in are sacrosanct. On-time delivery is key. Hence it is extremely important that the entire team is fully aligned to the customer’s requirements. The…   Read more»

]]> 8eb65793c1eb8a7d9faf8e379861c057 Aasutosh Purohit replied to the topic "Review of Combination products" - https://medicaldevicecourses.com/activity/p/15330/ Wed, 15 May 2019 19:05:18 -0400 Combination products are typically marketed under a marketing authorization type associated with the constituent part that provides the primary mode of action (PMOA) for the combination product (i.e., a new drug application (NDA) or abbreviated new drug application (ANDA) if…   Read more»

]]> 4a18c9741edff962e35df94e788a4717 Aasutosh Purohit replied to the topic "Discussion Topic: Integrating Six Sigma into Project Planning" - https://medicaldevicecourses.com/activity/p/15236/ Wed, 15 May 2019 19:04:18 -0400 Six Sigma: Six Sigma is the method of choice for reducing variance and eliminating the number of defects that a process produces. Six Sigma relies heavily on statistical analysis and offers an arsenal of tools that analyze current performance and…   Read more»

]]> 1c333b2e1b8ce46df328dc45ce21be04 Aasutosh Purohit replied to the topic "Planning Phase" - https://medicaldevicecourses.com/activity/p/15175/ Wed, 15 May 2019 19:03:42 -0400 The planning phase is the phase where the project solution is further developed in much detail. Its the phase where the steps necessary to meet the project’s objective are planned. In this step, the team identifies all of the work…   Read more»

]]> df32da609b4109fba6c504bf649f5dae Aasutosh Purohit replied to the topic "Process Groups vs. Project Lifecycle Phases" - https://medicaldevicecourses.com/activity/p/15094/ Wed, 15 May 2019 19:03:00 -0400 Is it necessary to create a process group for every project by a company or a single process group looks after all the projects being done in the company?

]]> 6ec72f2491135a11bc730ad4ea2bc3fe Aasutosh Purohit replied to the topic "Risk Management" - https://medicaldevicecourses.com/activity/p/15092/ Wed, 15 May 2019 19:02:59 -0400 A risk is an uncertain event which can have a positive or a negative effect on a project’s final product. As a project manager or a team member of that project, one of the important things I will do is…   Read more»

]]> 82715234378f0bf1ddd400b23d6631b6 Aasutosh Purohit replied to the topic "What is Risk Management Plan?" - https://medicaldevicecourses.com/activity/p/14956/ Wed, 15 May 2019 19:01:42 -0400 A risk to the product is something that every company faces, may it be a startup or a large established company. Risk management is something how the company or the firm tackles the risk.Risk Management is the process of identifying,…   Read more»

]]> 7718dd97efd3947b2fcdde53fc164946 Aasutosh Purohit replied to the topic "Pros and Cons of the 3 Organizational Structures" - https://medicaldevicecourses.com/activity/p/14886/ Wed, 15 May 2019 19:01:04 -0400 In my point of view each organization has pros and cons. but personally I feel that I am more comfortable working on a project based organization. Because in such type of organization, a person gets to work in various types…   Read more»

]]> 7e13b78431d7d845b1ae4a14ab8fe267 Aasutosh Purohit replied to the topic "Your Ideas about How to prepare/write a Successful Project Proposal" - https://medicaldevicecourses.com/activity/p/14877/ Wed, 15 May 2019 19:00:59 -0400 A Project Proposal is a detailed description of a series of activities that deal with solving a certain problem. It’s nothing but just converting the project plan into a project document. The project proposal should provide a logical presentation of…   Read more»

]]> 50aa5ca1486727098bb2e6f4f3e6763c Aasutosh Purohit replied to the topic "Determining project priority" - https://medicaldevicecourses.com/activity/p/14743/ Wed, 15 May 2019 18:59:41 -0400 In my point of view, Science is a vast field and it is never too late to try new things. If we think that something has the capability to make a future in the market as a device, it should…   Read more»

]]> 4e2da3248024913170aadfa6acf1a07a Aasutosh Purohit replied to the topic "FDA about upgraded device" - https://medicaldevicecourses.com/activity/p/14739/ Wed, 15 May 2019 18:59:39 -0400 According to FDA’s regulation, a premarket notification must be submitted to FDA when there is (a) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification…   Read more»

]]> bbd33209cfdec80bf441101152edfbec Aasutosh Purohit replied to the topic "FDA Approves First Digital Pill in USA" - https://medicaldevicecourses.com/activity/p/14668/ Wed, 15 May 2019 18:59:01 -0400 After reading few articles about the “digital drug”, I think that in one side, its one of the best invention whereas on another side there are some issues which had to be corrected before releasing it into the market. As…   Read more»

]]> 2848ec7159839a37b0f376b4ccad5e51 Aasutosh Purohit replied to the topic "Best timing for validation and verification" - https://medicaldevicecourses.com/activity/p/14587/ Wed, 15 May 2019 18:58:16 -0400 According to me, verification is about making something correctly whereas validation is about building a right product that sustains in the market for a longer period of time. The verification process is all about checking at regular interval if the…   Read more»

]]> 6573afcc5dd9bddc9b0388ead6c59934 Aasutosh Purohit replied to the topic "Initiating a Project Idea" - https://medicaldevicecourses.com/activity/p/14547/ Wed, 15 May 2019 18:57:54 -0400 Initiating a project idea is the hardest as well as the most crucial part of any project that needs to be done successfully. Because no one believes you until you have a full proof idea that will have a great…   Read more»

]]> 3db39c76d3addc76a39f89e06f24a867 Aasutosh Purohit replied to the topic "Ideal project team" - https://medicaldevicecourses.com/activity/p/14522/ Wed, 15 May 2019 18:57:38 -0400 Hello everyone, I guess everyone in this thread has already talked a lot about the skills and the kind of team they require for their team. Still in my point of view, to have a perfect team, I will need…   Read more»

]]> 9b751548e9782d13a97e50dcba15eb0b Aasutosh Purohit posted a new topic "Priorities for Projects" - https://medicaldevicecourses.com/activity/p/10731/ Wed, 15 May 2019 16:36:02 -0400 Every project comes with a priority. and it needs to be completed within a certain point of time. Is it possible that a Single project can focus on more than one priorities?

]]> 542d56e7b287c9f4757ebaae436607da Aasutosh Purohit posted a new topic "Sponsorship for companies" - https://medicaldevicecourses.com/activity/p/10730/ Wed, 15 May 2019 16:36:02 -0400 For any project to start either its a big firm or a small firm, sponsorship is the most impoatant thing. So my question is How do a project manager/supervisor work with sponsors?

]]> 75f3ac74bfd63a08e0014c9cbe111afd Aasutosh Purohit posted a new topic "Different PM techniques based on size" - https://medicaldevicecourses.com/activity/p/10722/ Wed, 15 May 2019 16:35:54 -0400 It was mentioned in the slides that companies with different sizes i.e. smaller companies use different project management techniques than that of larger companies. Why are the project management techniques different for the companies based on their size?

]]> 41eede1aabe5199058a0600477665d39 Aasutosh Purohit posted a new topic "QA vs QC" - https://medicaldevicecourses.com/activity/p/10714/ Wed, 15 May 2019 16:35:50 -0400 In the lecture we studied about Quality Assurance and Quality control. How these both are different from each other?

]]> eed36231eb4cd4c539c2d3d8eb30f551 Aasutosh Purohit posted a new topic "kinds of changes in PM" - https://medicaldevicecourses.com/activity/p/10702/ Wed, 15 May 2019 16:35:43 -0400 What are the different kinds of changes during the monitoring and controlling phase of a project and how do they affect a project?

]]> 6ac66c0d8f36402cd25f2634642decce Aasutosh Purohit posted a new topic "planned value vs actual costs" - https://medicaldevicecourses.com/activity/p/10695/ Wed, 15 May 2019 16:35:40 -0400 In the recent lecture, we learned what are planned value and actual costs in monitoring and controlling phase. so my question is how the planned value and actual costs matter in the monitoring and controlling phase?

]]> de9ceb37e50bb044740453c3109de5b7 Aasutosh Purohit posted a new topic "Design verification vs design validation" - https://medicaldevicecourses.com/activity/p/10681/ Wed, 15 May 2019 16:35:33 -0400 What is the main difference between design verification and design validation?

]]> cada7e9fb3ddb005beb50d446b77a83d Aasutosh Purohit posted a new topic "Design validation" - https://medicaldevicecourses.com/activity/p/10677/ Wed, 15 May 2019 16:35:31 -0400 Testing aimed at ensuring that a product or system fulfills the defined user needs and specified requirements, under specified operating conditions is called Design Validation. My question is why is design validation an important factor in project management?

]]> 24fc1a7c3f08b110a6e67a2c4805a13b Aasutosh Purohit posted a new topic "Review of Combination products" - https://medicaldevicecourses.com/activity/p/10674/ Wed, 15 May 2019 16:35:29 -0400 We know that a combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. So…   Read more»

]]> 4a3c9c8a6e3db368c47792696d81fd54 Aasutosh Purohit posted a new topic "task Scheduling :factors" - https://medicaldevicecourses.com/activity/p/10666/ Wed, 15 May 2019 16:35:25 -0400 we know that in Project scheduling or task scheduling, the following are the steps needed: Defining Activities, doing proper Estimates, determining Dependencies and assigning Resources. According to you guys, are there any other factors that need to be added to…   Read more»

]]> 9d2b1f607216e54ba6e2d1d5a01fd5e2 Aasutosh Purohit posted a new topic "Categorization of Medical Devices" - https://medicaldevicecourses.com/activity/p/10645/ Wed, 15 May 2019 16:35:14 -0400 We all know that companies categorize their products into different levels. So my query is on what basis the medical devices are being categorized?

]]> ad73ba45e9c3ef0e875395ad296e7f38 Aasutosh Purohit posted a new topic "Funding in Medical Devices Industry" - https://medicaldevicecourses.com/activity/p/10644/ Wed, 15 May 2019 16:35:14 -0400 We all know that Funding is one of the major key factors for any company. so my concern is if there is a lack of funding for a project by the company or firm but the project idea has a…   Read more»

]]> 46cca94c1d6dde4f9547544b38fa19f2 Aasutosh Purohit posted a new topic "Project management team" - https://medicaldevicecourses.com/activity/p/10640/ Wed, 15 May 2019 16:35:11 -0400 How important is picking a proper project team for any employee of a company for a project?

]]> cf94634c9c03170756a94d39bc10680f Aasutosh Purohit started the topic Priorities for Projects in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7575/ Sun, 29 Apr 2018 19:05:07 -0400 Every project comes with a priority. and it needs to be completed within a certain point of time. Is it possible that a Single project can focus on more than one priorities?

]]> 0 1565334e5b10f33ec3c7dc1a1b286ecc Aasutosh Purohit started the topic Sponsorship for companies in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7574/ Sun, 29 Apr 2018 19:02:10 -0400 For any project to start either its a big firm or a small firm, sponsorship is the most impoatant thing. So my question is How do a project manager/supervisor work with sponsors?

]]> 0 b3f1e8cf3680ee45dd38aa853c88b030 Aasutosh Purohit replied to the topic What it an NCMR in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7573/ Sun, 29 Apr 2018 18:50:22 -0400 Any item, part or product with one or more characteristics which depart from the requirements of the specification, safety, legality, regularity & quality or other approved product description. Nonconformity refers to a failure to comply with the requirement.A requirement is a need, expectation, or obligation; it can be stated or implied by an…[Read more]

]]> 0 41111fc6477ff20bc2909744e011c183 Aasutosh Purohit replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7431/ Sun, 22 Apr 2018 18:30:13 -0400 For me, I will work as an engineer for 3-4 years and learn most of the technical stuff that I can use to enhance my career so that i have a proper experience and then I will shift to management positions.

]]> 0 5a8dbbc449b0dad503c733f6732250b7 Aasutosh Purohit started the topic Different PM techniques based on size in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7427/ Sun, 22 Apr 2018 18:13:45 -0400 It was mentioned in the slides that companies with different sizes i.e. smaller companies use different project management techniques than that of larger companies. Why are the project management techniques different for the companies based on their size?

]]> 0 4bca3db589d842bf51cab3bd81dc220b Aasutosh Purohit replied to the topic Factors to look for while preparing schedule and budget for Clinical Trial in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7425/ Sun, 22 Apr 2018 17:47:55 -0400 There are many factors to look for while preparing schedule and budget for clinical trials.

1. Start-Up Fees:
This Start-Up Fee includes all of the Internal Committee and IRB application preparations, budget negotiations, regulatory document preparation as well as on-site visits and study protocol training. It may also include the Pharmacy…[Read more]

]]> 0 f519be44c94e9e9190b263703a8e9866 Aasutosh Purohit started the topic QA vs QC in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7301/ Mon, 16 Apr 2018 00:40:22 -0400 In the lecture we studied about Quality Assurance and Quality control. How these both are different from each other?

]]> 0 192a7d9878aac28044f4c73abbf3aa4d Aasutosh Purohit replied to the topic Analogous vs Bottom Up Cost Estimating in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7293/ Sun, 15 Apr 2018 23:46:13 -0400 Analogous Estimating:
This technique is used to estimate the project cost when very little detail about the project is available. Therefore, this technique does not provide a very reliable estimation. The primary benefits of this technique are its lower cost and quick results.

In analogous estimation, the cost of the project is estimated by…[Read more]

]]> 0 4d288b2e6e9909c0a71e6d00c72aff64 Aasutosh Purohit replied to the topic Things to look for in a contract while selecting a supplier in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7290/ Sun, 15 Apr 2018 20:49:06 -0400 Choosing the right supplier involves much more than scanning a series of price lists. The choice will depend on a wide range of factors such as value for money, quality, reliability and services.

A key criterion in selecting the right supplier is value. Cost should not be the only factor. The total cost of ownership should also be considered,…[Read more]

]]> 0 6247a58cf4ed60e7e8cd12f963875acf Aasutosh Purohit replied to the topic how the PM handles budget cut? in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/7100/ Sun, 01 Apr 2018 21:33:57 -0400 It’s a matter of Change of Management on the project, and as such should be already part of the project plan in the first place. Every project will face issues of one kind or another, and project plan should provide how such changes are handled formally within the project.

In this case cost estimation is related to elements needed in order to a…[Read more]

]]> 0 234a683abafeab4b1f71111a721cfbd8 Aasutosh Purohit started the topic kinds of changes in PM in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/7097/ Sun, 01 Apr 2018 21:23:51 -0400 What are the different kinds of changes during the monitoring and controlling phase of a project and how do they affect a project?

]]> 0 dbfc23802cd632b33f523d2a4acd0b5d Aasutosh Purohit replied to the topic Things help to understand project status other than project matrix in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/7073/ Sat, 31 Mar 2018 21:38:21 -0400 Factors other than matrix that can help detect the status of the project and help us have a rough estimate of time frame for the project depends on how well we manage these factors:
-Integration
– Scope
– Time/schedule
– Costs
– Quality
– Human resources
– Communication
– Risk
– Procurement
– Stakeholders

]]> 0 9183795eb72ec7f5cfb6faeb51f61179 Aasutosh Purohit replied to the topic Importance of Metrics in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6989/ Mon, 26 Mar 2018 00:22:57 -0400 Different project management metrics can be defined based on a project’s objective and complexity. However, the following five typically cover the most important measurements:

Productivity – This metric allows project managers to assess the utilization of resources. It compares the total effort to the budgeted effort, which has a direct imp…[Read more]

]]> 0