Medical Device Courses | hg93 | Activity https://medicaldevicecourses.com/members/hg93/activity/ Activity feed for hg93. Fri, 24 Apr 2026 18:57:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e127260a245704e9f312f5acdeef4d87 hg93 replied to the topic "Alternatives dispute resolution" - https://medicaldevicecourses.com/activity/p/11372/ Wed, 15 May 2019 16:44:19 -0400 Hi, Here are other few, out of court dispute resolutions which are referred to as Alternative Dispute Resolution (ADR). Minitrials A minitrial is a process by which the attorneys for the parties present a short version of the case to…   Read more»

]]> c61573c84cba1573a267fa8165dae04f hg93 replied to the topic "Anti-kickback & Stark Cases" - https://medicaldevicecourses.com/activity/p/11369/ Wed, 15 May 2019 16:44:17 -0400 Under the Anti-Kickback Statute, a company commits fraud when it offers doctors and other health care providers financial incentives to use the business’s products or services, for which payment may be made under Medicare, Medicaid or other federally-funded healthcare programs….   Read more»

]]> d6093e85ba9e3e51c5907b0c0cbe8af6 hg93 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11350/ Wed, 15 May 2019 16:44:08 -0400 Krunal, Nice discussion topic! The term ‘verbal contract’ actually refers to any agreement which can be expressed in words, and that means all written contracts as well as those that have only been discussed. The major practical differences between ‘oral…   Read more»

]]> b97c8bd54710f95a29c1acbf25a8d36f hg93 replied to the topic "Organization Type vs. Effectiveness" - https://medicaldevicecourses.com/activity/p/11262/ Wed, 15 May 2019 16:43:26 -0400 This is a good discussion topic related to the organizational structure. According to PMBOK, organizational structure is defined as an enterprise environmental factor which affects the availability of resources and influences how the projects are conducted. As discussed by Dr….   Read more»

]]> 6cd27614558c88601e04a223085e9677 hg93 replied to the topic "Manage Risk" - https://medicaldevicecourses.com/activity/p/11185/ Wed, 15 May 2019 16:40:46 -0400 One of the points for avoiding risk I would like to add to manage risk is Exploitation. Exploitation: To exploit the risk. The techniques mentioned above are great when they have a negative impact in the project but what if…   Read more»

]]> 9b35bc6e6b1171352cb9e5f8bad6bd8e hg93 replied to the topic "Factors Contributing to Risk Values" - https://medicaldevicecourses.com/activity/p/11183/ Wed, 15 May 2019 16:40:43 -0400 Risk index number = impact of risk event x probability of occurrence The impact of the risk event is commonly assessed on a scale of 1 to 5, where 1 and 5 represent the minimum and maximum possible impact of…   Read more»

]]> 98c02c3de737e87513f77ce5590b5795 hg93 replied to the topic "Combination Product Phase I clinical Studies" - https://medicaldevicecourses.com/activity/p/10997/ Wed, 15 May 2019 16:38:40 -0400 Design plans are just a plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR.Design control for 1st phase include the following 16 tasks: Identification of…   Read more»

]]> e458f9bd481f3e8a0948b15051a8b9c8 hg93 replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/10881/ Wed, 15 May 2019 16:37:30 -0400 Great discussion so far! Verification and validation are two critical elements of product development. One informs the elements of a product’s design, while the other looks at those design elements in the hands of users. Although often used synonymously, these…   Read more»

]]> 02d7236d4cf4a1801969333e8bcd11b4 hg93 posted a new topic "Collaboration projects" - https://medicaldevicecourses.com/activity/p/10415/ Wed, 15 May 2019 16:33:23 -0400 As Dr.Simon mentioned, there are several types of organizational structure which a company can function within, each having their own set of advantages and disadvantages. Consider collaboration projects, that is, two or more companies come together to develop and manufacture…   Read more»

]]> 26602c8b27e250f6db62d84ddf5aeb93 hg93 posted a new topic "Organizational structure and Culture both leading to project success?" - https://medicaldevicecourses.com/activity/p/10414/ Wed, 15 May 2019 16:33:22 -0400 As Dr.Simon have mentioned there are different types of organizational structures. Any project is affected by project management system, culture, style, organizational structure and also project management office can influence the project.According to me, organizational structure is responsible for organizational…   Read more»

]]> 19ada9e6796badf3300a834b6df69fd0 hg93 posted a new topic "Risk Management - Identification" - https://medicaldevicecourses.com/activity/p/10409/ Wed, 15 May 2019 16:33:20 -0400 Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way to avoid project catastrophes. Continuously applying the right risk management…   Read more»

]]> 1de8fda6ee8acf303b3670a200182c3f hg93 posted a new topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/10389/ Wed, 15 May 2019 16:33:07 -0400 As discussed closing phase is one of the most critical aspects of a project and can sometimes be looked at as a project of its own. Dr. Simon this week discussed the basis of the Design Transfer, an important part…   Read more»

]]> b1273417d7255df8ef0d26c6dd661724 hg93 posted a new topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/10388/ Wed, 15 May 2019 16:33:06 -0400 As mentioned in the lecture, design review meetings happen at the end of each stage in the project. They are critical because they facilitate communication between the design team, management, and the customer. The design team provides information about the…   Read more»

]]> 118db2f7077a8124be3eea1203c0d2d2 hg93 posted a new topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10382/ Wed, 15 May 2019 16:33:03 -0400 Design Development Plan (DDP) contains: *final scope statement *scope management plan *quality management plan *communications management plan *team member list/responsibilities Communication management plan is the most important part of the DDP because communication management plan contains information on how to…   Read more»

]]> be3e81cfa9a7b8eb1f05be7d7f95fa3c hg93 posted a new topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10381/ Wed, 15 May 2019 16:33:03 -0400 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through…   Read more»

]]> 90283bf8a915f58c3ed8be985ada3fbf hg93 replied to the topic Alternatives dispute resolution in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/868/ Sun, 04 Dec 2016 02:51:51 -0500 Hi,

Here are other few, out of court dispute resolutions which are referred to as Alternative Dispute Resolution (ADR).

Minitrials

A minitrial is a process by which the attorneys for the parties present a short version of the case to a panel, often comprised of the clients themselves and a neutral intermediary who chairs the process. Expert…[Read more]

]]> 0 864edc58b3dc07e73c5ecddd47b05447 hg93 replied to the topic Anti-kickback & Stark Cases in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/865/ Sun, 04 Dec 2016 02:14:25 -0500 Under the Anti-Kickback Statute, a company commits fraud when it offers doctors and other health care providers financial incentives to use the business’s products or services, for which payment may be made under Medicare, Medicaid or other federally-funded healthcare programs. The illegal kickbacks can be cash payments, but often include other i…[Read more]

]]> 0 7adf8e948b1fce18d45541e05571c330 hg93 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/836/ Thu, 01 Dec 2016 20:33:14 -0500 Krunal,
Nice discussion topic!

The term ‘verbal contract’ actually refers to any agreement which can be expressed in words, and that means all written contracts as well as those that have only been discussed. The major practical differences between ‘oral contracts’ and ‘written’ ones are to refer to a contract that’s only spoken about; it’s…[Read more]

]]> 0 0047ec344859def4d613d700d415fd1e hg93 started the topic Collaboration projects in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/767/ Mon, 28 Nov 2016 02:19:36 -0500 As Dr.Simon mentioned, there are several types of organizational structure which a company can function within, each having their own set of advantages and disadvantages. Consider collaboration projects, that is, two or more companies come together to develop and manufacture a product.

In your opinion,which organizational structure would be more…[Read more]

]]> 0 5a4ce5287ffe469952a22a243e644b83 hg93 started the topic Organizational structure and Culture both leading to project success? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/732/ Sun, 27 Nov 2016 15:50:38 -0500 As Dr.Simon have mentioned there are different types of organizational structures. Any project is affected by project management system, culture, style, organizational structure and also project management office can influence the project.According to me, organizational structure is responsible for organizational culture.It plays a significant…[Read more]

]]> 0 e80a26850f98420439dfd49761a9ad91 hg93 replied to the topic Organization Type vs. Effectiveness in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/731/ Sun, 27 Nov 2016 15:44:00 -0500 This is a good discussion topic related to the organizational structure. According to PMBOK, organizational structure is defined as an enterprise environmental factor which affects the availability of resources and influences how the projects are conducted.
As discussed by Dr. Simon that there is the disadvantage that there is limited knowledge…[Read more]

]]> 0 434bf070acb99fecf3338c7eda145c6c hg93 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/631/ Mon, 21 Nov 2016 04:24:18 -0500 One of the points for avoiding risk I would like to add to manage risk is Exploitation.

Exploitation: To exploit the risk. The techniques mentioned above are great when they have a negative impact in the project but what if the risk has the positive impact?

For example, the risk that the new washing machines are so popular that we don’t have e…[Read more]

]]> 0 979ac802ae0ede74a5331ca8e07b6d2c hg93 started the topic Risk Management - Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/630/ Mon, 21 Nov 2016 04:18:48 -0500 Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way to avoid project catastrophes. Continuously applying the right risk management tools early on and all the way through the life of the project will ensure that risks…[Read more]

]]> 0 d2fe0e7052c41015f58a7ea2ec3dd4b9 hg93 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/628/ Mon, 21 Nov 2016 04:11:21 -0500 Risk index number = impact of risk event x probability of occurrence

The impact of the risk event is commonly assessed on a scale of 1 to 5, where 1 and 5 represent the minimum and maximum possible impact of an occurrence of a risk (usually in terms of financial losses).
The probability of occurrence is assessed on a scale from 1 to 5, where 1…[Read more]

]]> 0 d8c24f197902cd32b8b65b2bab69f784 hg93 replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/391/ Sun, 13 Nov 2016 19:45:08 -0500 Design plans are just a plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR.Design control for 1st phase include the following 16 tasks:

Identification of the regulatory pathway based upon the device risk classification and applicable harmonized standards.

Development of a risk…[Read more]

]]> 0 d8c24f197902cd32b8b65b2bab69f784 hg93 replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/390/ Sun, 13 Nov 2016 19:45:08 -0500 Design plans are just a plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR.Design control for 1st phase include the following 16 tasks:

Identification of the regulatory pathway based upon the device risk classification and applicable harmonized standards.

Development of a risk…[Read more]

]]> 0 a792a9776dcfa6b7c00f81b411f60174 hg93 replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/388/ Sun, 13 Nov 2016 19:45:08 -0500 Design plans are just a plan. You can and should change that plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR. You can make your plan as detailed as you need to, but I recommend starting simple and adding detail. Your first version of a design plan should include the following 16…[Read more]

]]> 0 e4797611ab77dc39173052ec876f5c98 hg93 started the topic Design Transfer in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/309/ Wed, 09 Nov 2016 22:12:41 -0500 As discussed closing phase is one of the most critical aspects of a project and can sometimes be looked at as a project of its own. Dr. Simon this week discussed the basis of the Design Transfer, an important part of the closing. It includes finishing off the Design Controls and moving the device from prototype form to production ready. It takes…[Read more]

]]> 0 b18f17b8bfcd310df478e7d44fe2b279 hg93 started the topic Design Transfer in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/308/ Wed, 09 Nov 2016 22:12:41 -0500 As discussed closing phase is one of the most critical aspects of a project and can sometimes be looked at as a project of its own. Dr. Simon this week discussed the basis of the Design Transfer, an important part of the closing. It includes finishing off the Design Controls and moving the device from prototype form to production ready. It…[Read more]

]]> 0 707e70dcaf4521e10ac49d8c0cdbe5a0 hg93 started the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/307/ Wed, 09 Nov 2016 22:07:52 -0500 As mentioned in the lecture, design review meetings happen at the end of each stage in the project. They are critical because they facilitate communication between the design team, management, and the customer. The design team provides information about the status of the project to the manager and customer and also receives feedback regarding the…[Read more]

]]> 0 98d8f1bfff900d71a69fed5dfd933945 hg93 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/224/ Mon, 07 Nov 2016 00:45:37 -0500 Great discussion so far!

Verification and validation are two critical elements of product development. One informs the elements of a product’s design, while the other looks at those design elements in the hands of users. Although often used synonymously, these alliterative terms sit on opposite sides of the product development life c…[Read more]

]]> 0 23a9b28f3a74a616af4ea08c28aa5d33 hg93 started the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/102/ Wed, 02 Nov 2016 16:02:19 -0400 Design Development Plan (DDP) contains:
*final scope statement
*scope management plan
*quality management plan
*communications management plan
*team member list/responsibilities

Communication management plan is the most important part of the DDP because communication management plan contains information on how to contact people and the rules to…[Read more]

]]> 0 0342966e1e9b03d329a20558879febdb hg93 started the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/101/ Wed, 02 Nov 2016 15:59:51 -0400 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development.

Open up the discussion about Design Con…[Read more]

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