Medical Device Courses | sdl3 | Activity https://medicaldevicecourses.com/members/sdl3/activity/ Activity feed for sdl3. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 884f2c52ccbe99ffa5db29d1a605bafd sdl3 replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/11355/ Wed, 15 May 2019 16:44:10 -0400 As stated here, there is a pretty big difference between an NDA/ CDA and a patent. There are also a few versions of NDA/CDAs, a one way to the company or from the company and a two way. Comapnies can…   Read more»

]]> a2d72bf1872ebf0a76e3a1520fee7b9e sdl3 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11211/ Wed, 15 May 2019 16:42:58 -0400 This is a tough question since you don’t always get a say in who is available to work with. But as a general rule, it is easier to work with people you have a good relationship with until you fundamentally…   Read more»

]]> a675700e847ec23ff5700699c9f6b781 sdl3 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11210/ Wed, 15 May 2019 16:42:58 -0400 I think my organization is a matrix type, but it also falls into a few othe categories from the website that another classmate posted (http://blog.hubspot.com/marketing/team-structure-diagrams#sm.00000pxiq60kn9dkivhcsc0fqkmx8). We have a CEO, VPs of different functional groups but also of different franchises which…   Read more»

]]> 305947de68a41f2dfbb5ad21ec590d4c sdl3 replied to the topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/11207/ Wed, 15 May 2019 16:42:57 -0400 I would agree with the matrix type organization as being very successful. It reduces redundancy and fosters working together to prevent re-inventing things that are required. Especially in medical devices where there is typically 1 core device with different variations…   Read more»

]]> 355748c114d1012a13bd8675710225e5 sdl3 replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/11096/ Wed, 15 May 2019 16:39:52 -0400 This website explains this concept of AFAP and something else called “As Low As Reasonably Practicable” (ALARP). The idea is that the device has as many of its risks either removed or mitigated as much as possible with 2 categories…   Read more»

]]> d95d85c42a189fe0849606143cf37613 sdl3 replied to the topic "Customer Needs, Business Requirements, Test Plan" - https://medicaldevicecourses.com/activity/p/11057/ Wed, 15 May 2019 16:39:30 -0400 I work in Sustaining Engineering and though we don’t usually come up with new products and develop them, we do put a lot of work into getting and documenting VOC (voice of customer), and testing our solutions against the documented…   Read more»

]]> d5af1868f93db995397b1b801df9a448 sdl3 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/11056/ Wed, 15 May 2019 16:39:30 -0400 I agree as well. We have had many issues with timelines being unrealistic becasue they are set from above instead of by the people actually doing the work. In addition we miss holidays, forget to consider production (we are a…   Read more»

]]> a05f02519c06b3361c96242e9096e849 sdl3 replied to the topic "Making up tests for design verification and validation" - https://medicaldevicecourses.com/activity/p/10970/ Wed, 15 May 2019 16:38:25 -0400 To your point, the ASTM and ISO standard test methods are very relevant to this question. They also can be modified for different applications after purchasing the test. The engineer does make up the test but they can use standards…   Read more»

]]> c04ab9a41860939c3e565f4542e19110 sdl3 replied to the topic "Discussion Topic: Risk Management, Risk Analysis" - https://medicaldevicecourses.com/activity/p/10951/ Wed, 15 May 2019 16:38:14 -0400 The ISO14971 regulation directly involves Risk management. A few of the requirements are to have risks identified and documented, a risk management plan, and risk control. These can be in the form of documents, policies, and procedures that the company…   Read more»

]]> 98b5650e391e8471a2efbce4cb1c5f3e sdl3 replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/10876/ Wed, 15 May 2019 16:37:27 -0400 One thing, possibly less significant than many of the other suggestions here, is the difficulty in improving. If documentation is not done well and thoroughly from the beginning, it makes it difficult to improve later. Rationale and successful improvements cannot…   Read more»

]]> b5367272f5effabda975e75cbf16001b sdl3 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/10819/ Wed, 15 May 2019 16:36:52 -0400 Coming from the “Continuous Improvement” mindset, I would think that the “snapshot” that EU regulatory bodies focus on is really only from a practicality standpoint. Each time the EU regulatory bodies perform an audit, they are looking for issues at…   Read more»

]]> 09830903401e7b8a0ea015f2d8787203 sdl3 posted a new topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/10392/ Wed, 15 May 2019 16:33:10 -0400 Hi, I wanted to talk about something that come up occasionally at work. When I work on projects, I need to reference standards for various controls in the medical device market, like ISO, FDA, USP, AATB, ASTM, and others. However,…   Read more»

]]> 0925dda16d64e7437cfedfdc1b913291 sdl3 replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/843/ Fri, 02 Dec 2016 19:35:22 -0500 As stated here, there is a pretty big difference between an NDA/ CDA and a patent. There are also a few versions of NDA/CDAs, a one way to the company or from the company and a two way. Comapnies can provide information to and from each other in a two way NDA without much worry that their information will be shared to other people outside the…[Read more]

]]> 0 5097ec07de5ca739e7b8e09b52888a7b sdl3 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/667/ Wed, 23 Nov 2016 14:48:18 -0500 This is a tough question since you don’t always get a say in who is available to work with. But as a general rule, it is easier to work with people you have a good relationship with until you fundamentally disagree on something and cannot make a compromise. Also, you may not have friends in all departments and will eventually need to work with…[Read more]

]]> 0 bbc6ae0af66bc7453cdc1fb4bff0b2af sdl3 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/666/ Wed, 23 Nov 2016 14:38:00 -0500 I think my organization is a matrix type, but it also falls into a few othe categories from the website that another classmate posted (http://blog.hubspot.com/marketing/team-structure-diagrams#sm.00000pxiq60kn9dkivhcsc0fqkmx8).

We have a CEO, VPs of different functional groups but also of different franchises which represent markets. But because…[Read more]

]]> 0 ea65417c68bc080cd1b04099668d9eb8 sdl3 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/662/ Wed, 23 Nov 2016 14:03:30 -0500 I would agree with the matrix type organization as being very successful. It reduces redundancy and fosters working together to prevent re-inventing things that are required. Especially in medical devices where there is typically 1 core device with different variations for slightly different markets. Even in larger organizations, this type of work…[Read more]

]]> 0 a35e658fa2645d6f5c3a48a126bc271b sdl3 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/516/ Thu, 17 Nov 2016 13:31:30 -0500 This website explains this concept of AFAP and something else called “As Low As Reasonably Practicable” (ALARP). The idea is that the device has as many of its risks either removed or mitigated as much as possible with 2 categories of exception. One is not necessarily reducing risk with additional or redundant alarms or controls. The other is t…[Read more]

]]> 0 0185e6938c914ec71a1de1b0d30de63e sdl3 replied to the topic Customer Needs, Business Requirements, Test Plan in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/461/ Mon, 14 Nov 2016 13:21:37 -0500 I work in Sustaining Engineering and though we don’t usually come up with new products and develop them, we do put a lot of work into getting and documenting VOC (voice of customer), and testing our solutions against the documented VOC. There are also a lot of failed projects that don’t work becasue the engineer failed to get proper VOC or didn’t…[Read more]

]]> 0 f7a6e694a88f8f3b784308dc4fcce474 sdl3 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/460/ Mon, 14 Nov 2016 13:16:33 -0500 I agree as well. We have had many issues with timelines being unrealistic becasue they are set from above instead of by the people actually doing the work. In addition we miss holidays, forget to consider production (we are a 24/7 facility with little room for shifting), and one big one is forgetting to account for other countries holidays/…[Read more]

]]> 0 61e193e43b0a661e76bed9d60b0829c5 sdl3 replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/348/ Fri, 11 Nov 2016 13:49:23 -0500 To your point, the ASTM and ISO standard test methods are very relevant to this question. They also can be modified for different applications after purchasing the test. The engineer does make up the test but they can use standards as guidelines and there are widely accepted statistical methods to analyse results. Ultimately the decision comes to…[Read more]

]]> 0 2e6b7c4d576b616315c59735dd013f03 sdl3 started the topic Expense of Regulations in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/325/ Thu, 10 Nov 2016 13:03:16 -0500 Hi,

I wanted to talk about something that come up occasionally at work. When I work on projects, I need to reference standards for various controls in the medical device market, like ISO, FDA, USP, AATB, ASTM, and others. However, I have noticed that in order to use them, the company has to purchase them and they are not cheap. You also don’t get…[Read more]

]]> 0 be3b81625edac9f74f6f3846d6180d0c sdl3 replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/324/ Thu, 10 Nov 2016 12:54:41 -0500 The ISO14971 regulation directly involves Risk management. A few of the requirements are to have risks identified and documented, a risk management plan, and risk control. These can be in the form of documents, policies, and procedures that the company must follow to ensure quality product is delivered to the customer and that employees are safe…[Read more]

]]> 0 cce6a7f0d584f417971bf68ccaecbc11 sdl3 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/217/ Sun, 06 Nov 2016 22:35:45 -0500 One thing, possibly less significant than many of the other suggestions here, is the difficulty in improving. If documentation is not done well and thoroughly from the beginning, it makes it difficult to improve later. Rationale and successful improvements cannot be made as easily when new employees cannot understand the reason for the previous…[Read more]

]]> 0 7080a7dea026bd46de8d2e5e45528f19 sdl3 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/115/ Thu, 03 Nov 2016 17:05:04 -0400 Coming from the “Continuous Improvement” mindset, I would think that the “snapshot” that EU regulatory bodies focus on is really only from a practicality standpoint. Each time the EU regulatory bodies perform an audit, they are looking for issues at that time, not necessarily from 10 years prior- though that’s not to say those documents are off l…[Read more]

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