Medical Device Courses | nda4 | Activity https://medicaldevicecourses.com/members/nda4/activity/ Activity feed for nda4. Fri, 24 Apr 2026 20:02:28 -0400 https://buddypress.org/?v= en-US 30 hourly 2 db864fa72fc16f86743154d910f38ad3 nda4 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11375/ Wed, 15 May 2019 16:44:21 -0400 Just to add to what has been stated, In my opinion I would prefer a written agreement instead of verbal. I believe that whenever there is a mutual understanding of what is decided, then legal issues can be prevented or…   Read more»

]]> b4477adcbf1fabff3c768e3075ee1ba0 nda4 replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/11374/ Wed, 15 May 2019 16:44:21 -0400 It’s also important to note that a NDA is a contract. And contract law is an entirely separate field from patent law. How contracts are interpreted is a matter of state law, and interpretations vary from state to state.

]]> c36d7db00d02cb447171bb687ffcb02f nda4 replied to the topic "Alternatives dispute resolution" - https://medicaldevicecourses.com/activity/p/11373/ Wed, 15 May 2019 16:44:20 -0400 In addition to what has been stated, I’d like to add: Neutral Evaluation In neutral evaluation, each party gets a chance to present the case to a neutral person called an “evaluator.” The evaluator then gives an opinion on the…   Read more»

]]> 40b916cd3f6a80802448b0080522c32d nda4 replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/11368/ Wed, 15 May 2019 16:44:17 -0400 Hello everyone, Although I understand Roberto’s perspective, I also agree that the restrictions are important and necessary. Effective January 2012, the Sunshine Act required that pharmaceutical companies and durable medical equipments suppliers report gifts to physicians in excess of $25….   Read more»

]]> ab43fc06581bc5036dabfec9230611f6 nda4 replied to the topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/11224/ Wed, 15 May 2019 16:43:05 -0400 I will have to agree as well. I would prefer the matrix organization as it also allows for greater flexibility in terms of outsourcing. In my experience, some projects that can be done outside the company are easily contracted and…   Read more»

]]> 5b927b4a6d0450f7f8b6edef74edde3f nda4 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11223/ Wed, 15 May 2019 16:43:04 -0400 In my current job, I work in a project based/matrix organization. Depending on the need, I am pulled into projects outside my direct functional therapeutic area as needed. I like the matrix structure since it allows for enhanced growth and…   Read more»

]]> 1a30c578f2aa827a056e12ce41efbb1d nda4 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11222/ Wed, 15 May 2019 16:43:03 -0400 I agree that project teams should consist of representatives from each function in order to receive contribution from all roles. I have noticed in my experience, that having a mixture of people with varying levels of expertise can be helpful…   Read more»

]]> 4ad42eed9eb98939f7bcb0e11b50c413 nda4 replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/11148/ Wed, 15 May 2019 16:40:19 -0400 Very interesting article, Khemraj. I agree with you. Just to add it is very easy for risk managers to become occupationally tunnel-visioned. However, the job is to manage risk, not to avoid it unnecessarily. Every business action involves risk. Even…   Read more»

]]> c436e4eeeb53cea1367110a2dfb9aea7 nda4 replied to the topic "Manage Risk" - https://medicaldevicecourses.com/activity/p/11145/ Wed, 15 May 2019 16:40:17 -0400 I like how you pointed out the importance of avoidance in high severity scenarios. It is also important to know in terms of cost, risk acceptance does not reduce any effects however it is still considered a strategy. This strategy…   Read more»

]]> afdd7dbf952f3605c5ee1f3d8badc624 nda4 replied to the topic "Manage Risk" - https://medicaldevicecourses.com/activity/p/11144/ Wed, 15 May 2019 16:40:17 -0400 I agree with you Luisa, I’d also like to add that risk transference is the involvement of handing risk off to a willing third party. In my opinion, in the case of low severity I think it is a good…   Read more»

]]> 7eb2a4cd5fbe338e8642b3e9f3bf3811 nda4 replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/11083/ Wed, 15 May 2019 16:39:45 -0400 Personally, I would hope the techs and surgeon’s are aware of what is in the label (such as the risks) prior to using the product. Perhaps through training taken in advance. I agree , that in the surgery example, it…   Read more»

]]> d57c1ec7c7761052a3bf96bb26268607 nda4 replied to the topic "Risk management methods" - https://medicaldevicecourses.com/activity/p/11078/ Wed, 15 May 2019 16:39:42 -0400 Great post. Just to add onto what has been stated. Risk ranking and filtering is also particularly helpful in situations in which the portfolio of risks and the underlying consequences to be managed are diverse and difficult to compare using…   Read more»

]]> c87535129f4a15f63f211f04621b6d14 nda4 replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11076/ Wed, 15 May 2019 16:39:41 -0400 I agree that the risk analysis is team based and involves checks along the way. The team should begin with a thorough identification of all potential and/or known hazards and develop an estimation of the risk(s) for each hazard. In…   Read more»

]]> e6d8cb153a7dc63f25899721677c5525 nda4 replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10946/ Wed, 15 May 2019 16:38:11 -0400 Hi Grzegorz, it is true like you have said that design control is important in order to ensure quality and correct errors. It is also important to note that design controls are required for all Class II and Class III…   Read more»

]]> 3c6b4f20aaa880b0af559a49af6bb26a nda4 replied to the topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/10943/ Wed, 15 May 2019 16:38:10 -0400 I agree that in certain instances, it could benefit the company to outsource the design transfer. For one thing, it is more cost effective. If the vendor follows all the specifications and is trained well than effective design transfer can…   Read more»

]]> faab23c11ff0fed2822339c39d7b230d nda4 replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/10942/ Wed, 15 May 2019 16:38:09 -0400 Thank you Himang for the great question. I don’t have experience conducting design review meetings. But from experience in review meetings as a whole, I can say it is best to keep the number of invitees medium sized since when…   Read more»

]]> b747f88fd2a32393a4b96a6129078dda nda4 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10935/ Wed, 15 May 2019 16:38:05 -0400 Although I agree with you Murad on clearly establishing roles and responsibilities, I think that the scope is also important to acknowledge early on in order to make sure the team stays on track and doesn’t veer off course. Working…   Read more»

]]> 47e8e8591bad0149c8a90827a5d8a3ab nda4 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10934/ Wed, 15 May 2019 16:38:05 -0400 I would have to disagree that I don’t think there is any one aspect of the Design Development plan that is more important than the other. In order to produce a high quality product there needs to be good communication…   Read more»

]]> c0107275583d95412e0cf1f0f6061372 nda4 replied to the topic "Design Transfer and Challenges" - https://medicaldevicecourses.com/activity/p/10933/ Wed, 15 May 2019 16:38:04 -0400 I agree with the statement that one of the flaws of design transfer occurs when there is an issue in transition of a product design to manufacturing environment. In order to ensure that the design of the medical device can…   Read more»

]]> b61e96cfd4aa3cc24aba3048815c7c2e nda4 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/873/ Sun, 04 Dec 2016 04:14:37 -0500 Just to add to what has been stated, In my opinion I would prefer a written agreement instead of verbal. I believe that whenever there is a mutual understanding of what is decided, then legal issues can be prevented or least have documented evidence when there is an infraction. Writing a formal agreement involves the review and assistance of legal…[Read more]

]]> 0 2e86bcf4d297b557f626590f7286c30c nda4 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/872/ Sun, 04 Dec 2016 04:14:37 -0500 Just to add to what’s been stated, In my opinion I would prefer a written agreement instead of verbal. I believe that whenever there is a mutual understanding of what is decided, then legal issues can be prevented or least have documented evidence when there is an infraction. Writing a formal agreement involves the review and assistance of legal…[Read more]

]]> 0 815f5ac5109b9072498c24a5f9223121 nda4 replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/871/ Sun, 04 Dec 2016 04:07:44 -0500 It’s also important to note that a NDA is a contract. And contract law is an entirely separate field from patent law. How contracts are interpreted is a matter of state law, and interpretations vary from state to state.

]]> 0 1b6c766b1ab1c428cb25c72001c87d95 nda4 replied to the topic Alternatives dispute resolution in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/870/ Sun, 04 Dec 2016 03:41:45 -0500 In addition to what has been stated, I’d like to add:

Neutral Evaluation
In neutral evaluation, each party gets a chance to present the case to a neutral person called an “evaluator.” The evaluator then gives an opinion on the strengths and weaknesses of each party’s evidence and arguments and about how the dispute could be resolved. The…[Read more]

]]> 0 5022f8844f237519c42e6b10922c1d6a nda4 replied to the topic Alternatives dispute resolution in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/869/ Sun, 04 Dec 2016 03:41:45 -0500 In addition to what has been stated, I’d like to add a few more:

Case Evaluation

Case evaluation is a non-binding process in which parties to a dispute present the facts and the issues to be determined to an experienced neutral case evaluator. The case evaluator advises the parties on the strengths and weaknesses of their respective positions,…[Read more]

]]> 0 09acb94aa546676c82272150aed150e5 nda4 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/864/ Sat, 03 Dec 2016 16:37:55 -0500 Hello everyone,

Although I understand Roberto’s perspective, I also agree that the restrictions are important and necessary. Effective January 2012, the Sunshine Act required that pharmaceutical companies and durable medical equipments suppliers report gifts to physicians in excess of $25. I think this is a fair amount, since like Andrew and…[Read more]

]]> 0 dddc3abf8e752f7e4ec7198aed54634d nda4 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/863/ Sat, 03 Dec 2016 16:37:55 -0500 Hello everyone,

Although I understand Roberto’s perspective, I also agree that the restrictions are important and necessary. Effective January 2012, the Sunshine Act required that pharmaceutical companies and durable medical equipments suppliers report gifts to physicians in excess of $25. I think this is a fair amount, since like Andrew and…[Read more]

]]> 0 ed1be85707dbd437ec92a21d27e45ffa nda4 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/862/ Sat, 03 Dec 2016 16:37:55 -0500 Hello everyone,

Although I understand Roberto’s perspective, I also agree that the restrictions are important and necessary. Effective January 2012, the Sunshine Act required that pharmaceutical companies and durable medical equipments suppliers report gifts to physicians in excess of $25. I think this is a fair amount, since like Andrew and…[Read more]

]]> 0 194081fa68420a13881d42cf67306bb6 nda4 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/683/ Thu, 24 Nov 2016 01:49:47 -0500 I will have to agree as well. I would prefer the matrix organization as it also allows for greater flexibility in terms of outsourcing. In my experience, some projects that can be done outside the company are easily contracted and the outsource personnel are expected to support whole functional areas. However, I must also add that in this…[Read more]

]]> 0 384c82e2ddfce15d9e6ef24029c94916 nda4 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/682/ Thu, 24 Nov 2016 01:41:01 -0500 In my current job, I work in a project based/matrix organization. Depending on the need, I am pulled into projects outside my direct functional therapeutic area as needed. I like the matrix structure since it allows for enhanced growth and career development. It is a great opportunity to work with diverse areas across the organization and continue…[Read more]

]]> 0 1cbe9c9b68a09cbb1f8642df86703f15 nda4 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/681/ Thu, 24 Nov 2016 00:31:53 -0500 I agree that project teams should consist of representatives from each function in order to receive contribution from all roles. I have noticed in my experience, that having a mixture of people with varying levels of expertise can be helpful especially in the case of learning. I think having good interpersonal skills is something that is a great…[Read more]

]]> 0 97505dc3687ae13f088f03f22ed93116 nda4 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/592/ Sun, 20 Nov 2016 22:28:48 -0500 Very interesting article, Khemraj. I agree with you. Just to add it is very easy for risk managers to become occupationally tunnel-visioned. However, the job is to manage risk, not to avoid it unnecessarily. Every business action involves risk. Even standing still and clinging to the status quo entails risk. Risk is inherent in business as in…[Read more]

]]> 0 22fa50a4a529a20caecc2c37ce25b99b nda4 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/589/ Sun, 20 Nov 2016 21:44:38 -0500 I like how you pointed out the importance of avoidance in high severity scenarios. It is also important to know in terms of cost, risk acceptance does not reduce any effects however it is still considered a strategy. This strategy is a common option when the cost of other risk management options such as avoidance or limitation may outweigh the…[Read more]

]]> 0 6661f190eb3e9cef0901cb32f79f7ec1 nda4 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/588/ Sun, 20 Nov 2016 21:39:46 -0500 I agree with you Luisa, I’d also like to add that risk transference is the involvement of handing risk off to a willing third party. In my opinion, in the case of low severity I think it is a good idea if a company outsources certain operations such as customer service, payroll services, etc. This can be beneficial for a company if a transferred…[Read more]

]]> 0 f89b7114ee98f830cc9af84d75c70917 nda4 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/587/ Sun, 20 Nov 2016 21:39:46 -0500 I agree with you Luisa, I’d also like to add that risk transference is the involvement of handing risk off to a willing third party. In my opinion, in the case of low severity I think it is a good idea if a company outsources certain operations such as customer service, payroll services, etc. This can be beneficial for a company if a transferred…[Read more]

]]> 0 8f7a6e9d8db15cd68ef7710f370e347f nda4 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/498/ Tue, 15 Nov 2016 22:00:11 -0500 Personally, I would hope the techs and surgeon’s are aware of what is in the label (such as the risks) prior to using the product. Perhaps through training taken in advance. I agree , that in the surgery example, it is hard to mitigate risk.

]]> 0 00c5a4caed91666d9a57774949f59004 nda4 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/497/ Tue, 15 Nov 2016 22:00:11 -0500 Personally, I would hope the techs and surgeon’s are aware of what is in the label prior to using the product. Perhaps through training taken in advance. I agree , that in the surgery example, it is hard to mitigate risk, but I would expect a warning label if it is needed.

]]> 0 7fcf15e865fe973c70cff098d51f93e0 nda4 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/496/ Tue, 15 Nov 2016 22:00:11 -0500 Personally, I would hope the techs and surgeon’s are aware of what is in the label prior to using the product. I agree , that in the surgery example, it is hard to mitigate risk, but I would expect a warning label if it is needed.

]]> 0 2ce9afb9586755d2ba787ecace853e9c nda4 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/489/ Tue, 15 Nov 2016 20:30:24 -0500 Great post. Just to add onto what has been stated.

Risk ranking and filtering is also particularly helpful in situations in which the portfolio of risks and the underlying consequences to be managed are diverse and difficult to compare using a single tool. Risk ranking can also be useful for management to evaluate both quantitatively-assessed…[Read more]

]]> 0 843dbe6c4fe3aa01697da00fb9570bca nda4 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/488/ Tue, 15 Nov 2016 20:30:24 -0500 Great post. Just to add onto what has been stated. Another risk management tool is:

Risk ranking and filtering- This method is used for comparing and ranking risks. Risk ranking of complex systems typically involves evaluation of multiple diverse quantitative and qualitative factors for each risk. The tool involves breaking down a basic risk…[Read more]

]]> 0 6e386e15cb6f4fdb7743f8c70c99d52a nda4 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/491/ Tue, 15 Nov 2016 19:47:50 -0500 I agree that the risk analysis is team based and involves checks along the way. The team should begin with a thorough identification of all potential and/or known hazards and develop an estimation of the risk(s) for each hazard. In a three-tiered version, the severity, probability of occurrence, and detectability of each hazard are evaluated,…[Read more]

]]> 0 ca68c33fff3980bf20a90de9a4fb7b37 nda4 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/490/ Tue, 15 Nov 2016 19:47:50 -0500 I agree that the risk analysis is team based and involves checks along the way. The team should begin with a thorough identification of all potential and/or known hazards and develop an estimation of the risk(s) for each hazard. In a three-tiered version, the severity, probability of occurrence, and detectability of each hazard are evaluated,…[Read more]

]]> 0 c5f817494507e1f463b675985faa9de7 nda4 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/486/ Tue, 15 Nov 2016 19:47:50 -0500 According to the ICH Q9 Guidance, the risk assessment decision tree is the same in medical devices and pharma. Interestingly, in addition to the FMECA as mentioned in the lectures the Fault Tree Analysis is used as a risk management tool. The FTA tool (see IEC 61025) is an approach that assumes failure of the functionality of a product or process.…[Read more]

]]> 0 e0152078761dba0862b9f0c4ce369c90 nda4 replied to the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/318/ Wed, 09 Nov 2016 23:48:17 -0500 Hi Grzegorz, it is true like you have said that design control is important in order to ensure quality and correct errors. It is also important to note that design controls are required for all Class II and Class III medical devices developed in the US as part of the Quality Management System (QMS) and IDE. Also, it is important to note, that…[Read more]

]]> 0 48fd316c5e3fe028eda9396ab09d1ffa nda4 replied to the topic Design Transfer in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/314/ Wed, 09 Nov 2016 23:17:31 -0500 I agree that in certain instances, it could benefit the company to outsource the design transfer. For one thing, it is more cost effective. If the vendor follows all the specifications and is trained well than effective design transfer can lower material and production costs, decrease product time to market, increase product quality, and generate…[Read more]

]]> 0 89800d892dd252feaad2058171c964ed nda4 replied to the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/313/ Wed, 09 Nov 2016 23:04:23 -0500 Thank you Himang for the great question. I don’t have experience conducting design review meetings. But from experience in review meetings as a whole, I can say it is best to keep the number of invitees medium sized since when too many people are included sometimes the conversations can be unproductive. Usually teams consist of one representative…[Read more]

]]> 0 45221406f8646ee3834292d57b7b443e nda4 replied to the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/312/ Wed, 09 Nov 2016 23:04:23 -0500 Thank you Himang for the great question. I don’t have experience conducting design review meetings. But from experience in review meetings as a whole, I can say it is best to keep the number of invitees medium sized since when too many people are included sometimes the conversations can be unproductive. Usually teams consist of one representative…[Read more]

]]> 0 afc07a8ef4bebbcf6f638b5ef97a34ea nda4 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/300/ Wed, 09 Nov 2016 20:51:58 -0500 Although I agree with you Murad on clearly establishing roles and responsibilities, I think that the scope is also important to acknowledge early on in order to make sure the team stays on track and doesn’t veer off course. Working out of scope can also cost the company a lot of money and resources by missing deadlines of the DDP. As someone else…[Read more]

]]> 0 6e453f2322269b5763c3652f5bd9ac1d nda4 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/299/ Wed, 09 Nov 2016 20:46:08 -0500 I would have to disagree that I don’t think there is any one aspect of the Design Development plan that is more important than the other. In order to produce a high quality product there needs to be good communication and the team members have to make sure they work within the scope of the project.

]]> 0 0a0da454556c52077f75b35d82c048ff nda4 replied to the topic Design Transfer and Challenges in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/297/ Wed, 09 Nov 2016 18:53:22 -0500 I agree with the statement that one of the flaws of design transfer occurs when there is an issue in transition of a product design to manufacturing environment. In order to ensure that the design of the medical device can be correctly translated into production specifications, particular care should be taken when the product involves new and…[Read more]

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