https://medicaldevicecourses.com/members/sjm39/activity/ Activity feed for sjm39. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 4f6c3dc4744967cd48fd526602e91e33 https://medicaldevicecourses.com/activity/p/11354/ Wed, 15 May 2019 16:44:10 -0400 An NDA is a contract that is a matter of state law, where a patent is a federal document, and therefore, interpreted uniformly throughout the country. If you sign a NDA with a company then they are obliged to honor…   Read more»

]]> e88f50c5b36097b5373a310e6e3ac121 https://medicaldevicecourses.com/activity/p/11353/ Wed, 15 May 2019 16:44:09 -0400 I believe you mentioned the two biggest methods but another method out of court dispute resolution is just negotiating. This is the most basic means of settling a dispute and usually the first option. Negotiating can be conducted between the…   Read more»

]]> d2d1208066a172e3d0b107700df49818 https://medicaldevicecourses.com/activity/p/11352/ Wed, 15 May 2019 16:44:09 -0400 As several people have mentioned I also was expecting the course to be more about specific medical devices rather than the whole industry process. However, I still really enjoyed this class and think it will be greatly beneficial for me…   Read more»

]]> 8158b0f91aa2acf33694e7f09d093896 https://medicaldevicecourses.com/activity/p/11239/ Wed, 15 May 2019 16:43:13 -0400 As mentioned, the privilege of picking one’s ideal team is not always an option. If one does have a choice though, knowledge in the department is more important than the relationship. Having a good relationship is beneficial for good communication…   Read more»

]]> 30cd986dc589a04c8d644bbdc7266790 https://medicaldevicecourses.com/activity/p/11238/ Wed, 15 May 2019 16:43:13 -0400 I believe the matrix org structure would be the best for most companies. It provides a well balanced structure as the employees have to report to at least two bosses; their functional manager and product manager. This helps a company…   Read more»

]]> 1927fca335e0287c6bd98992103847b8 https://medicaldevicecourses.com/activity/p/11236/ Wed, 15 May 2019 16:43:11 -0400 I believe it would be more difficult working as a project manager in the matrix based organization. There are three types of matrix based organizations. Functional matrix is when the functional manager has more power that the project manager, a…   Read more»

]]> f57f4725130deccdcd93e59c687296e9 https://medicaldevicecourses.com/activity/p/11134/ Wed, 15 May 2019 16:40:11 -0400 I agree with all of the methods mentioned but I believe the task analysis and error use analysis methodology is the best way to address usability risks. The task analysis helps to identify and document the environment in which the…   Read more»

]]> 368fbc307f3bf1e898e84e485993ce25 https://medicaldevicecourses.com/activity/p/11132/ Wed, 15 May 2019 16:40:10 -0400 I believe one of the most important mistakes mentioned was how risk management is not a life cycle process. It should be a living a document and updated accordingly. Complaints and feedback from the users should be heard; the market…   Read more»

]]> 58258e1ae0d0a7626547ee0586ff263a https://medicaldevicecourses.com/activity/p/11130/ Wed, 15 May 2019 16:40:09 -0400 For high severity of risk I would use mitigation and avoidance. A device with a high severity risk has the potential to kill or severely harm someone which is not only morally wrong but leads to huge lawsuits. It is…   Read more»

]]> 6f64d0d8802aadaae112a9c7a5e0e211 https://medicaldevicecourses.com/activity/p/11040/ Wed, 15 May 2019 16:39:18 -0400 I also had to do a business requirement document in capstone here at NJIT and I see the similarities between this and the design validation process. The business requirement document had us list all the costumer needs and make sure…   Read more»

]]> 6252150a7ca2efd7eaf6ff0e5f73fea6 https://medicaldevicecourses.com/activity/p/11028/ Wed, 15 May 2019 16:39:12 -0400 Phase 1 clinical studies are done on a small group of participants after the drug or treatment has been proved safe on animals. Doctors use this phase to establish a good dosage range as well as collect data on the…   Read more»

]]> 90dad15ea52f36380bbe825fd04e7abd https://medicaldevicecourses.com/activity/p/11023/ Wed, 15 May 2019 16:39:09 -0400 As my classmates have mentioned the FDA does not demand specific tests for design verification or design validation. The FDA ensures good quality assurance practices with the 21 CFR Part 820.30 that Dr.Simon mentioned in his lecture. This regulation does…   Read more»

]]> 59ae22e0f869a2908f54d1d900b192d3 https://medicaldevicecourses.com/activity/p/10859/ Wed, 15 May 2019 16:37:14 -0400 AS sdl3 said, the Design Dossier or Tech File can be beneficial for audits as they only have to look back at the material that was updated since the last audit because of the new ‘snapshots’. I think this method…   Read more»

]]> 3f2cc43aad4742f2a9a2f324d3466c6e https://medicaldevicecourses.com/activity/p/10858/ Wed, 15 May 2019 16:37:13 -0400 I agree with what everyone has already said about inefficient design control leading to dangerous devices, lower quality, traceability of the product, or the FDA not allowing the product to get to the market. To add to all of this,…   Read more»

]]> f7519a4037e3241c4dddf2ec490e7551 https://medicaldevicecourses.com/activity/p/10856/ Wed, 15 May 2019 16:37:12 -0400 As Dr. Simon said, the DDP is often just used as a boiler plate placeholder in the DHF but it should be used as an underlying plan for the project. Therefore, all of the 5 parts you mentioned are important….   Read more»

]]> e0492dce1393a1f938392b3d52302760 https://medicaldevicecourses.com/activity/p/842/ Fri, 02 Dec 2016 17:41:33 -0500 An NDA is a contract that is a matter of state law, where a patent is a federal document, and therefore, interpreted uniformly throughout the country. If you sign a NDA with a company then they are obliged to honor it. If they take your idea and put it on the market, you have full capability of suing them. However, similar to what Viraj said, if a…[Read more]

]]> 0 ab73fa5145b4fdcaee07035be37d3cea https://medicaldevicecourses.com/activity/p/841/ Fri, 02 Dec 2016 17:18:30 -0500 I believe you mentioned the two biggest methods but another method out of court dispute resolution is just negotiating. This is the most basic means of settling a dispute and usually the first option. Negotiating can be conducted between the two parties or by a lawyer on behalf of a party. There are many benefits to settling a court dispute this…[Read more]

]]> 0 8cb1fc610e37466b97a6232e18604235 https://medicaldevicecourses.com/activity/p/840/ Fri, 02 Dec 2016 16:25:27 -0500 As several people have mentioned I also was expecting the course to be more about specific medical devices rather than the whole industry process. However, I still really enjoyed this class and think it will be greatly beneficial for me going forward. As I am an undergraduate student, this is the first class I have taken that has stressed not only…[Read more]

]]> 0 742af289bdec5ce0524790895451b127 https://medicaldevicecourses.com/activity/p/700/ Fri, 25 Nov 2016 20:33:07 -0500 As mentioned, the privilege of picking one’s ideal team is not always an option. If one does have a choice though, knowledge in the department is more important than the relationship. Having a good relationship is beneficial for good communication and compromising but it is only a bonus to being a good knowledgeable worker. If a team member does…[Read more]

]]> 0 d7b7330f504005fff5277b6cc68f66f5 https://medicaldevicecourses.com/activity/p/699/ Fri, 25 Nov 2016 19:36:49 -0500 I believe the matrix org structure would be the best for most companies. It provides a well balanced structure as the employees have to report to at least two bosses; their functional manager and product manager. This helps a company share resources and provide a unified environment. However, for a medical device company worldwide, I believe the…[Read more]

]]> 0 5e1cfd4db7937b88f966c236dd49fc85 https://medicaldevicecourses.com/activity/p/574/ Sun, 20 Nov 2016 19:15:47 -0500 I agree with all of the methods mentioned but I believe the task analysis and error use analysis methodology is the best way to address usability risks. The task analysis helps to identify and document the environment in which the task is conducted, the operators involved, the information required to perform the task, and the sources of…[Read more]

]]> 0 130b625fbb858602c23c5f6c49d9dc01 https://medicaldevicecourses.com/activity/p/572/ Sun, 20 Nov 2016 18:44:51 -0500 I believe one of the most important mistakes mentioned was how risk management is not a life cycle process. It should be a living a document and updated accordingly. Complaints and feedback from the users should be heard; the market size is usually much larger than the risk management staff and could see potential risks that the company may have…[Read more]

]]> 0 9388a04f726ab08f6efa2fe5680ad28d https://medicaldevicecourses.com/activity/p/570/ Sun, 20 Nov 2016 18:23:13 -0500 For high severity of risk I would use mitigation and avoidance. A device with a high severity risk has the potential to kill or severely harm someone which is not only morally wrong but leads to huge lawsuits. It is important to avoids or mitigate these types of risks as they would cause the most financial loss to a company. I would use acceptance…[Read more]

]]> 0 25635679077985562941fe746b5f5d51 https://medicaldevicecourses.com/activity/p/443/ Mon, 14 Nov 2016 04:34:31 -0500 I also had to do a business requirement document in capstone here at NJIT and I see the similarities between this and the design validation process. The business requirement document had us list all the costumer needs and make sure we fulfilled them. This is similar in that validation checks that the inputs are the user needs or intended use and…[Read more]

]]> 0 34b99e05d4ee5142f27acf828e4aee67 https://medicaldevicecourses.com/activity/p/442/ Mon, 14 Nov 2016 04:34:31 -0500 I also had to do a business requirement document and I see the similarities between this and the design validation process. The business requirement document had us list all the costumer needs and make sure we fulfilled them. This is similar in that validation checks that the inputs are the user needs or intended use and then validates whether the…[Read more]

]]> 0 f3ae3d36325f3767c7e694116c6c40e0 https://medicaldevicecourses.com/activity/p/429/ Mon, 14 Nov 2016 02:46:37 -0500 Phase 1 clinical studies are done on a small group of participants after the drug or treatment has been proved safe on animals. Doctors use this phase to establish a good dosage range as well as collect data on the effects of the drug or treatment and its safeness. Clinical studies are a part of the validation process in design controls. If a…[Read more]

]]> 0 9f83e87dd0e7c2d583ee5d5c9075e7e5 https://medicaldevicecourses.com/activity/p/428/ Mon, 14 Nov 2016 02:46:37 -0500 Phase 1 clinical studies are done on a small group of participants after the drug or treatment has been proved safe on animals. Doctors use this phase to establish a good dosage range as well as collect data on the effects of the drug or treatment and its safeness. Clinical studies are a part of the validation process in design controls. If a…[Read more]

]]> 0 1c9f40f218d14ce52f48fce816988fd7 https://medicaldevicecourses.com/activity/p/423/ Mon, 14 Nov 2016 02:20:39 -0500 As my classmates have mentioned the FDA does not demand specific tests for design verification or design validation. The FDA ensures good quality assurance practices with the 21 CFR Part 820.30 that Dr.Simon mentioned in his lecture. This regulation does not describe the practices that must be used but establishes the framework that manufacturers…[Read more]

]]> 0 96ac161c6ca86220e55986fe1a0ccac7 https://medicaldevicecourses.com/activity/p/192/ Sun, 06 Nov 2016 15:59:21 -0500 AS sdl3 said, the Design Dossier or Tech File can be beneficial for audits as they only have to look back at the material that was updated since the last audit because of the new ‘snapshots’. I think this method can also be helpful if a product starts to fail after a change in design. One can easily compare the different snapshots and see where…[Read more]

]]> 0 9d2c401d1dad433d119855546f742739 https://medicaldevicecourses.com/activity/p/191/ Sun, 06 Nov 2016 15:31:39 -0500 I agree with what everyone has already said about inefficient design control leading to dangerous devices, lower quality, traceability of the product, or the FDA not allowing the product to get to the market. To add to all of this, design control is also a key factor in fixing any problems that arise. The Design History File (DHF) contains all of…[Read more]

]]> 0 5779f5c6ed7ff9b98d600709ede257a2 https://medicaldevicecourses.com/activity/p/188/ Sun, 06 Nov 2016 15:12:50 -0500 As Dr. Simon said, the DDP is often just used as a boiler plate placeholder in the DHF but it should be used as an underlying plan for the project. Therefore, all of the 5 parts you mentioned are important. If I had to pick which was the most important I would narrow it down to quality management plan and team member lists/responsibilities.…[Read more]

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