Medical Device Courses | hmp42 | Activity https://medicaldevicecourses.com/members/hmp42/activity/ Activity feed for hmp42. Fri, 24 Apr 2026 18:53:59 -0400 https://buddypress.org/?v= en-US 30 hourly 2 24c6308103eb240298f9c7f168178013 hmp42 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11351/ Wed, 15 May 2019 16:44:08 -0400 Hi all Nice discussion so far.Written agreements are important to avoid risk of genuine mistakes.It is legal way of doing things. Written agreement formally prevents one party from making the same verbal agreement with multiple other parties, protecting the business…   Read more»

]]> f9e70b5a395a8d7c9b17e6529ae43223 hmp42 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11336/ Wed, 15 May 2019 16:44:01 -0400 I would like to share my personal experience.Last semester,I took System Management for Medical Device-online course from Dr.Simon.While as a graduate student when i went to give my first in person interview for a pharma company,i would have not blessed…   Read more»

]]> 5b2d2e7374b49d63c374f5035119e2f1 hmp42 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11242/ Wed, 15 May 2019 16:43:15 -0400 Good discussion so far.I would like to shift a focus little bit.What if you do not have option to pick? Which is the situation in most of the time.In such cases one should have to look up for strategies to…   Read more»

]]> a13dbba5419b92a69a008fca19c35a9a hmp42 replied to the topic "Project Management Preferences" - https://medicaldevicecourses.com/activity/p/11229/ Wed, 15 May 2019 16:43:08 -0400 Very interesting topic Lamiaa. I believe it would be more challenging to work in matrix organization for a project manager.In matrix organization,the product manager would find himself working across functional lines to try to coordinate production schedules, inventories, cash flow,…   Read more»

]]> 98d160c2e8e1e250907a697843f47d61 hmp42 replied to the topic "Risk management methods" - https://medicaldevicecourses.com/activity/p/11131/ Wed, 15 May 2019 16:40:10 -0400 Good discussion so far! I would like to add more to HACCP-Hazard Analysis Critical Control Point. HACCP process could be divided as following. • Conduct a Hazard Analysis. • Identify Critical Control Points. • Establish the critical limits of the…   Read more»

]]> 2feca21078d4273ad76cfa3695e84558 hmp42 replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/11129/ Wed, 15 May 2019 16:40:09 -0400 Agree with all of you! As I was also going through Harvard Business review, they have listed top 6 mistakes made by executives for risk management. They are, • Risk is not only determined by predicting extreme events. • Take…   Read more»

]]> 2315723d7c82a8bedb18e410f49f8889 hmp42 replied to the topic "Sample Size Based on Risk Analysis" - https://medicaldevicecourses.com/activity/p/11127/ Wed, 15 May 2019 16:40:08 -0400 Selection of sample size for clinical study is always critical choice. Few samples do not represent size of target population. On the other hand, more samples than required put more individuals to the risk of the intervention. Additionally, it is…   Read more»

]]> 1fb0c9ef9992bb8006f4c0d6572b7897 hmp42 replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/10981/ Wed, 15 May 2019 16:38:31 -0400 Fady Validation is powerful tool to achieve highly effective product. As we all have learned, Verification is to look any flaws in the products, whereas Validation is necessary for judging it through end user’s perspective. In my opinion, even if…   Read more»

]]> bd7859af9a8d26fe4c233f9a12861dc9 hmp42 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/10980/ Wed, 15 May 2019 16:38:31 -0400 Hi Roberto You brought interesting topic and good discussion so far. As we are going to work towards our final project I would like to point out what to include when writing down meeting minutes. • Date, Time and Place…   Read more»

]]> 804c81f334260b4d70abad3c403d9037 hmp42 replied to the topic "Design Controls for Legacy Combination Products" - https://medicaldevicecourses.com/activity/p/10869/ Wed, 15 May 2019 16:37:21 -0400 Good Discussion so far. A legacy device is one that incorporated a drug before combination product regulations arrived. Many medical device manufacturers have mistakenly assumed that since legacy products were initially reviewed by Centers for Devices and Radiological Health (CDRH),…   Read more»

]]> 05525276488ac9929eb683fe8d825379 hmp42 replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/10836/ Wed, 15 May 2019 16:37:01 -0400 As per my understanding, Validation is concerned with making sure that the system meets the customer’s actual needs, while verification is concerned with whether the system is well-engineered, error-free, and so on. Verification will help to determine whether the software…   Read more»

]]> 7658ee2b3e04d3b2a7001e7a91c6f3bc hmp42 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10835/ Wed, 15 May 2019 16:37:01 -0400 I agree with most of you here. The company needs to manage different groups involved in design development, so for such part indeed communication management plan is very essential to mention responsibilities. It is basically a good mixture of activities…   Read more»

]]> c72da396fd22c9a43db67ff30a8355d4 hmp42 posted a new topic "Anti-kickback & Stark Cases" - https://medicaldevicecourses.com/activity/p/10416/ Wed, 15 May 2019 16:33:24 -0400 There are majorly 5 types of federal fraunds. (1) False Claims Act(FCA) (2) Anti-kickback Status(AKS) (3) Referral/Stark Law (4) The Exclusion Authorities (5) Civil Monetary Penalties Law(CMPL) As i was going through some articles about top most federal frauds that…   Read more»

]]> d6911764b9973783e27b0e1ab63ac47e hmp42 posted a new topic "Organizational Behavior Management" - https://medicaldevicecourses.com/activity/p/10412/ Wed, 15 May 2019 16:33:21 -0400 As Dr.Simon have stated organizational behavior is very important to improve performance. Recently i came across one interesting paper on organizational behavior management in healthcare. Organizational behavior management (OBM) focuses on what people do, analyzes , and then applies strategy…   Read more»

]]> e9fdc9e96311d89dff3f1881a36901eb hmp42 posted a new topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/10395/ Wed, 15 May 2019 16:33:12 -0400 As we all know before setting up Gantt Chart we should have detailed project plan. Some important factors while preparing Gantt Chart are, • Defining clear project settings. • Start date and end date. • Each task name and duration….   Read more»

]]> 37ccda5e1f2b4f26c242f5872ee78d41 hmp42 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/838/ Thu, 01 Dec 2016 20:56:51 -0500 Hi all

Nice discussion so far.Written agreements are important to avoid risk of genuine mistakes.It is legal way of doing things. Written agreement formally prevents one party from making the same verbal agreement with multiple other parties, protecting the business arrangement. Working on project involves so many plans to work out at the same…[Read more]

]]> 0 14eb7969268e3a6b8368efbae0a76f00 hmp42 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/837/ Thu, 01 Dec 2016 20:56:51 -0500 Hi all

Nice discussion do far.Written agreements are important to avoid risk of genuine mistakes.It is legal way of doing things. Written agreement formally prevents one party from making the same verbal agreement with multiple other parties, protecting the business arrangement. Working on project involves so many plans to work out at the same…[Read more]

]]> 0 db108d67574d1055ec98675df640f945 hmp42 started the topic Anti-kickback & Stark Cases in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/816/ Wed, 30 Nov 2016 18:27:02 -0500 There are majorly 5 types of federal fraunds.
(1) False Claims Act(FCA)
(2) Anti-kickback Status(AKS)
(3) Referral/Stark Law
(4) The Exclusion Authorities
(5) Civil Monetary Penalties Law(CMPL)

As i was going through some articles about top most federal frauds that are applicable to physicians,i got one interesting articles regrading cases which…[Read more]

]]> 0 102432001d132572fd54076d4718675f hmp42 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/815/ Wed, 30 Nov 2016 18:15:58 -0500 I would like to share my personal experience.Last semester,I took System Management for Medical Device-online course from Dr.Simon.While as a graduate student when i went to give my first in person interview for a pharma company,i would have not blessed myself so much for taking this course.For half an hour interview,i would have been speechless…[Read more]

]]> 0 57100b1e405cb349f7a360553907ee64 hmp42 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/704/ Sat, 26 Nov 2016 03:13:10 -0500 Good discussion so far.I would like to shift a focus little bit.What if you do not have option to pick? Which is the situation in most of the time.In such cases one should have to look up for strategies to manage conflict and disagreements. As PMBOK suggests some of the ways to manage conflicts are.

(1) Avoidance
(2) Compromise
(3) Delegation
(4)…[Read more]

]]> 0 44ff387ec0a2adb50553b222ae60f55f hmp42 started the topic Organizational Behavior Management in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/703/ Sat, 26 Nov 2016 00:42:54 -0500 As Dr.Simon have stated organizational behavior is very important to improve performance. Recently i came across one interesting paper on organizational behavior management in healthcare. Organizational behavior management (OBM) focuses on what people do, analyzes , and then applies strategy to improve what people do.

Behavior is influenced by…[Read more]

]]> 0 3d3b4f753e4ccd9c03b6ac7a02132f9d hmp42 replied to the topic Project Management Preferences in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/691/ Thu, 24 Nov 2016 18:17:54 -0500 Very interesting topic Lamiaa. I believe it would be more challenging to work in matrix organization for a project manager.In matrix organization,the product manager would find himself working across functional lines to try to coordinate production schedules, inventories, cash flow, and distribution patterns. Because he has approved all future…[Read more]

]]> 0 14aa1cd0d7f6bb82436b90728c7aa004 hmp42 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/571/ Sun, 20 Nov 2016 18:35:54 -0500 Good discussion so far! I would like to add more to HACCP-Hazard Analysis Critical Control Point. HACCP process could be divided as following.

• Conduct a Hazard Analysis.
• Identify Critical Control Points.
• Establish the critical limits of the control.
• Monitor your CCPs.
• Corrective Actions.
• Establish record keeping procedures.…[Read more]

]]> 0 d442b8dbd9d2131dff8cbd84f01074bf hmp42 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/569/ Sun, 20 Nov 2016 18:03:44 -0500 Agree with all of you! As I was also going through Harvard Business review, they have listed top 6 mistakes made by executives for risk management. They are,
• Risk is not only determined by predicting extreme events.
• Take recent advice but don’t Only refer to past.
• Relying on historical data.
• Overlooking Concealed risks.
• Not managing in…[Read more]

]]> 0 238fa45fcff41607f462296dc560119e hmp42 replied to the topic Sample Size Based on Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/567/ Sun, 20 Nov 2016 17:03:22 -0500 Selection of sample size for clinical study is always critical choice. Few samples do not represent size of target population. On the other hand, more samples than required put more individuals to the risk of the intervention. Additionally, it is wastage of time and resources.
Optimum number of participants required to be able to arrive at…[Read more]

]]> 0 5eb5631cfa1cf1101d539cb27b78c09a hmp42 replied to the topic Sample Size Based on Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/566/ Sun, 20 Nov 2016 17:03:22 -0500 Selection of sample size for clinical study is always critical choice. Few samples do not represent size of target population. On the other hand, more samples than required put more individuals to the risk of the intervention. Additionally, it is wastage of time and resources.
The calculation of an adequate sample size so it is crucial in any…[Read more]

]]> 0 29866193bc67527fa04cb62e6aa48ac7 hmp42 replied to the topic When is validation is not required? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/369/ Sat, 12 Nov 2016 19:19:20 -0500 Fady

Validation is powerful tool to achieve highly effective product. As we all have learned, Verification is to look any flaws in the products, whereas Validation is necessary for judging it through end user’s perspective. In my opinion, even if validation is not performed due to reasons listed above, it is always good practice to conduct h…[Read more]

]]> 0 5d42a396bac73d9f0937b4d3e131d651 hmp42 started the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/366/ Sat, 12 Nov 2016 18:06:58 -0500 As we all know before setting up Gantt Chart we should have detailed project plan. Some important factors while preparing Gantt Chart are,

• Defining clear project settings.
• Start date and end date.
• Each task name and duration.
• Connectivity between tasks.
• Including Resources.
• Simple to use for other project members.

I wish to hear fro…[Read more]

]]> 0 15952ed4566ec7dee01aaeff1d5cd394 hmp42 started the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/365/ Sat, 12 Nov 2016 18:06:58 -0500 As we all know before setting up Gantt Chart we should have detailed project plan. Some important factors while preparing Gantt Chart are,

• Defining clear project settings.
• Start date and end date.
• Each task name and duration.
• Connectivity between tasks.
• Including Resources.
• Simple to use for other project members.

I wish to hear fro…[Read more]

]]> 0 a2700cc7ddee9f6fb46d3b2427846afe hmp42 replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/363/ Sat, 12 Nov 2016 17:37:57 -0500 Hi Roberto
You brought interesting topic and good discussion so far. As we are going to work towards our final project I would like to point out what to include when writing down meeting minutes.

• Date, Time and Place of Meeting.
• Clear goal of meeting.
• Attendees list.
• Actions taken.
• Decisions made.
• Agenda for next meeting, if somethin…[Read more]

]]> 0 7880fc448655e193020b96bfe08a68a4 hmp42 replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/362/ Sat, 12 Nov 2016 17:37:57 -0500 Hi Roberto
You brought interesting topic and good discussion so far. As we are going to work towards our final project I would like to point out what to include when writing down meeting minutes.

• Date, Time and Place of Meeting.
• Clear goal of meeting.
• Attendees list.
• Actions taken.
• Decisions made.
• Agenda for next meeting, if somethin…[Read more]

]]> 0 6dec14c613535701ebac27fb8afa4cdc hmp42 replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/206/ Sun, 06 Nov 2016 19:16:35 -0500 Good Discussion so far. A legacy device is one that incorporated a drug before combination product regulations arrived. Many medical device manufacturers have mistakenly assumed that since legacy products were initially reviewed by Centers for Devices and Radiological Health (CDRH), but for combination products that is not true. Developing…[Read more]

]]> 0 b89209a4d7d98cc446641e1ddca21aab hmp42 replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/205/ Sun, 06 Nov 2016 19:16:35 -0500 Good Discussion so far. A legacy device is one that incorporated a drug before combination product regulations arrived. Many medical device manufacturers have mistakenly assumed that since legacy products were initially reviewed by Centers for Devices and Radiological Health (CDRH), but for combination products that is not true. Developing…[Read more]

]]> 0 7f1a916f02f6d85127eb791c7fd1bd3e hmp42 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/154/ Sat, 05 Nov 2016 03:13:33 -0400 As per my understanding, Validation is concerned with making sure that the system meets the customer’s actual needs, while verification is concerned with whether the system is well-engineered, error-free, and so on. Verification will help to determine whether the software is of high quality, but it will not ensure that the system is useful at c…[Read more]

]]> 0 096cd0488e9a5cb72f05b35b0a3dde88 hmp42 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/153/ Sat, 05 Nov 2016 03:13:33 -0400 As per my understanding, Validation is concerned with making sure that the system meets the customer’s actual needs, while verification is concerned with whether the system is well-engineered, error-free, and so on. Verification will help to determine whether the software is of high quality, but it will not ensure that the system is useful at c…[Read more]

]]> 0 3b4b2040e83b17b849ea54f94b24a92a hmp42 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/152/ Sat, 05 Nov 2016 03:13:33 -0400 As per my understanding, Validation is concerned with making sure that the system meets the customer’s actual needs, while verification is concerned with whether the system is well-engineered, error-free, and so on. Verification will help to determine whether the software is of high quality, but it will not ensure that the system is useful at c…[Read more]

]]> 0 661fc9d7feab65904a0911d8a84a4990 hmp42 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/155/ Sat, 05 Nov 2016 02:38:22 -0400 I agree with most of you here. The company needs to manage different groups involved in design development, so for such part indeed communication management plan is very essential to mention responsibilities. It is basically a good mixture of activities listed. Some of the important aspects about design development plan are,
• Identify all s…[Read more]

]]> 0 8e40bafa7594e7b4c1f31952e5525994 hmp42 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/150/ Sat, 05 Nov 2016 02:38:22 -0400 I agree with most of you here. The company needs to manage different groups involved in design development, so for such part indeed communication management plan is very essential to mention responsibilities. It is basically a good mixture of activities listed. Some of the important aspects about design development plan are,
• Identify all s…[Read more]

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