Medical Device Courses | Khemraj Singh | Activity https://medicaldevicecourses.com/members/ks282/activity/ Activity feed for Khemraj Singh. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 87e2a9d918fe856ea99105495b76b7a6 Khemraj Singh replied to the topic "Consultants NDAs and CDAs" - https://medicaldevicecourses.com/activity/p/11408/ Wed, 15 May 2019 16:44:43 -0400 I believe something like this would definitely violate your NDA or CDA. IMO your manager made a great decision. Just having the wrong logo is enough for a violation depending on what is patented. Companies like Tiffany Co. actually patent…   Read more»

]]> 0ec9cf914250903d9bcaf117ec3d55b7 Khemraj Singh replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11393/ Wed, 15 May 2019 16:44:32 -0400 I really enjoyed this course. As a student of BME, I find classes in this field do not translate itself to industry all that well. Classes seem more geared toward the functionality of medical devices. Yes, this is certainly important,…   Read more»

]]> f0d0cee56d857fb9b59b2d7b9abbe5d6 Khemraj Singh replied to the topic "Collaboration projects" - https://medicaldevicecourses.com/activity/p/11304/ Wed, 15 May 2019 16:43:46 -0400 For collaboration projects, I would consider a Product Organizational Structure. This structure has managers reporting to the head of the company by product type. Each division within the organization is dedicated to a particular product line. This certainly makes collaboration…   Read more»

]]> ea27ce58c5a06ca3b8a09e7a2aab4402 Khemraj Singh replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11300/ Wed, 15 May 2019 16:43:44 -0400 Firstly, individuals need to be selected that are the best fit for roles within the scope of the project. Individuals who possess the knowledge and have unique backgrounds (diversity!) will be heavily sought out. From there, I would consider a…   Read more»

]]> 654b5376d3259685528b7686ee7d97b4 Khemraj Singh replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11248/ Wed, 15 May 2019 16:43:18 -0400 I work in a matrix organization as a Manufacturing Engineer. I love this organizational style because information travels relatively quickly. Just last week I needed help from Regulatory concerning a project. Many members in Regulatory were out due to the…   Read more»

]]> 821f6bb6a47e9a339ec5a5b555e06bc2 Khemraj Singh replied to the topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/11156/ Wed, 15 May 2019 16:40:23 -0400 Regulation and standards should be abided by regardless of cost. Calibrations/maintenance are costly, but must be done. Safety inspections – also costly but must be done. Subscribing to these databases are simply a necessity just like all the tasks above….   Read more»

]]> f4b9152477330b62d37fa3e7c69c54ad Khemraj Singh replied to the topic "The change from ALARP to AFAP" - https://medicaldevicecourses.com/activity/p/11147/ Wed, 15 May 2019 16:40:18 -0400 AFAP is deemed acceptable when death or serious deterioration of health is unlikely. ALARP is not acceptable with regard to economic consideration. ALARP has more to do with acceptability of the risk. Also ISO 14971 allows risks to be reduced…   Read more»

]]> b872cae6c9bc624d5dec41846bcf206e Khemraj Singh replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/11141/ Wed, 15 May 2019 16:40:15 -0400 From personal experience, I know that the most difficulty in risk management is the need to state a reason for the result. Filling out the risk management assessment gives results. These results, however, need to be further analyzed. After doing…   Read more»

]]> bc501d4c6b81edd0997b88a62db35c87 Khemraj Singh replied to the topic "Design Controls for Legacy Combination Products" - https://medicaldevicecourses.com/activity/p/10918/ Wed, 15 May 2019 16:37:55 -0400 Legacy devices can be existing devices, modified hardware, and modified software. Legacy medical devices should conform to IEC 62366, a standard that specifies usability requirements for the development of medical devices. Having a summary of known use errors is a…   Read more»

]]> a1fb02cf617c0353f21ce9fa58fa11b3 Khemraj Singh replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10908/ Wed, 15 May 2019 16:37:48 -0400 It’s very difficult to select one part of the DPP over the others. If I were to select one I would have to say scope management plan. This determines how the project scope should be defined, developed and verified. I…   Read more»

]]> 9ace62f1bfb4b753eb3f1d7f1ddee533 Khemraj Singh replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/10892/ Wed, 15 May 2019 16:37:37 -0400 In design control, there are “checks” to verify that everything (mostly) is accounted for. Companies must question whether the design outputs conform to the design inputs. Was the design done right? Was the right device designed? That being said, it…   Read more»

]]> 2cb1b82fbc708a4125015c7b6a3439b0 Khemraj Singh posted a new topic "Recent Examples of Kickback Allegations" - https://medicaldevicecourses.com/activity/p/10422/ Wed, 15 May 2019 16:33:27 -0400 We learned about Anti-kick back laws that help to avoid companies buying referrals through rewards and services. Are there any recent examples that you can name of medical device companies that suffered from kickback allegations? I’ll give one: http://www.startribune.com/may-29-kickback-charges-cost-medtronic-9-9m/260978651/ Medtronic…   Read…[Read more]

]]> 95283590db854700fd291fe1c0e47a8a Khemraj Singh replied to the topic Consultants NDAs and CDAs in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/909/ Mon, 05 Dec 2016 01:46:22 -0500 I believe something like this would definitely violate your NDA or CDA. IMO your manager made a great decision. Just having the wrong logo is enough for a violation depending on what is patented. Companies like Tiffany Co. actually patent the shade of blue/green they use!
I think copying a general layout is okay, just looked down upon. Copying…[Read more]

]]> 0 f44536a7ee7bf3b412a75ad066954052 Khemraj Singh replied to the topic Consultants NDAs and CDAs in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/908/ Mon, 05 Dec 2016 01:46:22 -0500 I believe something like this would definitely violate your NDA or CDA. IMO your manager made a great decision. Just by having the wrong logo is enough for a violation depending on what is patented. Companies like Tiffany Co. actually patent the shade of blue/green they use!
I think copying a general layout is okay, just looked down upon. Copying…[Read more]

]]> 0 f9bd7e088e6469afb963fa281b262f76 Khemraj Singh started the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/893/ Sun, 04 Dec 2016 23:25:27 -0500 We learned about Anti-kick back laws that help to avoid companies buying referrals through rewards and services. Are there any recent examples that you can name of medical device companies that suffered from kickback allegations?

I’ll give one: http://www.startribune.com/may-29-kickback-charges-cost-medtronic-9-9m/260978651/

Medtronic was…[Read more]

]]> 0 d494c0b02ba9c34f439c05efaa1c66ad Khemraj Singh started the topic Examples of the "Gray Area" in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/892/ Sun, 04 Dec 2016 23:25:27 -0500 We learned about Anti-kick back laws that help to avoid companies buying referrals through rewards and services. Are there any recent examples that you can name of medical device companies that suffered from kickback allegations?

I’ll give one: http://www.startribune.com/may-29-kickback-charges-cost-medtronic-9-9m/260978651/

Medtronic was…[Read more]

]]> 0 54e8d95a1a8801e6c8caba678a6472bb Khemraj Singh replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/891/ Sun, 04 Dec 2016 22:57:26 -0500 I really enjoyed this course. As a student of BME, I find classes in this field do not translate itself to industry all that well. Classes seem more geared toward the functionality of medical devices. Yes, this is certainly important, but definitely not enough since most students move into industry after graduation rather than academia. As an…[Read more]

]]> 0 a12a7d8c196e4ac67a4a3806a944ef9a Khemraj Singh replied to the topic Collaboration projects in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/777/ Mon, 28 Nov 2016 03:13:27 -0500 For collaboration projects, I would consider a Product Organizational Structure. This structure has managers reporting to the head of the company by product type. Each division within the organization is dedicated to a particular product line. This certainly makes collaboration among two or more companies easier, especially if a company is only…[Read more]

]]> 0 0d31566c31d8ad6262787e1ffa2a05ef Khemraj Singh replied to the topic Collaboration projects in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/776/ Mon, 28 Nov 2016 03:13:27 -0500 For collaboration projects, I would consider a Product Organizational Structure. This structure has managers reporting to the head of the company by product type. Each division within the organization is dedicated to a particular product line. This certainly makes collaboration among two or more companies easier, especially if a company is only…[Read more]

]]> 0 707b222cad9da3c0fac59dfd94de9e94 Khemraj Singh replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/772/ Mon, 28 Nov 2016 03:00:15 -0500 Firstly, individuals need to be selected that are the best fit for roles within the scope of the project. Individuals who possess the knowledge and have unique backgrounds (diversity!) will be heavily sought out. From there, I would consider a Gallup-style test that considers personality. Result-driven individuals, for example, will be strongly…[Read more]

]]> 0 d88f97cfb71c7f3c06796697b10187ed Khemraj Singh replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/711/ Sun, 27 Nov 2016 01:18:33 -0500 I work in a matrix organization as a Manufacturing Engineer. I love this organizational style because information travels relatively quickly. Just last week I needed help from Regulatory concerning a project. Many members in Regulatory were out due to the holidays. Because of the matrix-styled structure, I could contact anyone in the Regulatory…[Read more]

]]> 0 f6e87aada35b6986774b272953eb7e66 Khemraj Singh replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/601/ Mon, 21 Nov 2016 00:58:05 -0500 Regulation and standards should be abided by regardless of cost. Calibrations/maintenance are costly, but must be done. Safety inspections – also costly but must be done. Subscribing to these databases are simply a necessity just like all the tasks above. Each company (ISO, FDA, USP, etc.) needs to hire regulation specialists to verify that these…[Read more]

]]> 0 b61312a75003c3ad05cd02de43629521 Khemraj Singh replied to the topic The change from ALARP to AFAP in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/591/ Sun, 20 Nov 2016 22:15:03 -0500

AFAP is deemed acceptable when death or serious deterioration of health is unlikely. ALARP is not acceptable with regard to economic consideration. ALARP has more to do with acceptability of the risk. Also ISO 14971 allows risks to be reduced ALARP and the European Directives require all risks to be reduced AFAP without economic…[Read more]

]]> 0 b91f69474e0ef1332d3d88b9b6ea2de7 Khemraj Singh replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/582/ Sun, 20 Nov 2016 20:59:44 -0500 From personal experience, I know that the most difficulty in risk management is the need to state a reason for the result. Filling out the risk management assessment gives results. These results, however, need to be further analyzed.

After doing some perusing online, I found that another mistake in risk management is not creating an avoidance…[Read more]

]]> 0 ca4a8854720f5201c78fc3e99f0144de Khemraj Singh replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/277/ Mon, 07 Nov 2016 04:19:23 -0500 Legacy devices can be existing devices, modified hardware, and modified software. Legacy medical devices should conform to IEC 62366, a standard that specifies usability requirements for the development of medical devices. Having a summary of known use errors is a good start. A full use-related risk analysis should be performed. Additionally,…[Read more]

]]> 0 4ac73a43b4b2f36f8913e5e7fccd78a5 Khemraj Singh replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/276/ Mon, 07 Nov 2016 04:19:23 -0500 Legacy devices can be existing devices, modified hardware, and modified software. Legacy medical devices should conform to IEC 62366, a standard that specifies usability requirements for the development of medical devices. Having a summary of known use errors is a good start. A full use-related risk analysis should be performed. Primary operating…[Read more]

]]> 0 847b14180cc55dbcc9cfcfa0ce9fc8f1 Khemraj Singh replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/275/ Mon, 07 Nov 2016 04:19:23 -0500 Legacy devices can be existing devices, modified hardware, and modified software. Legacy medical devices should conform to IEC 62366, a standard that specifies usability requirements for the development of medical devices. Having a summary of known use errors is a good start. A full use-related risk analysis should be performed. Primary operating…[Read more]

]]> 0 8da91a2fdc9f7ea46ddb515d6c1b5aae Khemraj Singh replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/268/ Mon, 07 Nov 2016 03:23:40 -0500 It’s very difficult to select one part of the DPP over the others. If I were to select one I would have to say scope management plan. This determines how the project scope should be defined, developed and verified. I think a skilled team makes development that much easier. It’s certainly not a requirement. I can’t say the same for the project…[Read more]

]]> 0 8da91a2fdc9f7ea46ddb515d6c1b5aae Khemraj Singh replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/267/ Mon, 07 Nov 2016 03:23:40 -0500 It’s very difficult to select one part of the DPP over the others. If I were to select one I would have to say scope management plan. This determines how the project scope should be defined, developed and verified. I think a skilled team makes development that much easier. It’s certainly not a requirement. I can’t say the same for the project…[Read more]

]]> 0 b476f8b56efdee4abc0bc22aa9b9e307 Khemraj Singh replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/263/ Mon, 07 Nov 2016 03:23:40 -0500 It’s very difficult to select one part of the DPP over the others. I would have to say scope management plan. This determines how the project scope should be defined, developed and verified. I think a skilled team makes development that much easier. It’s certainly not a requirement. I can’t say the same for the project scope. This is the backbone…[Read more]

]]> 0 56b52d8ed7fa155d523f48e94728cbd8 Khemraj Singh replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/242/ Mon, 07 Nov 2016 02:09:20 -0500 In design control, there are “checks” to verify that everything (mostly) is accounted for. Companies must question whether the design outputs conform to the design inputs. Was the design done right? Was the right device designed? That being said, it seems like companies get tripped up when design verification and validation are not up to par.…[Read more]

]]> 0 6c9feb0c48ca1a5b7f2e15a74b49a665 Khemraj Singh became a registered member https://medicaldevicecourses.com/activity/p/238/ Mon, 07 Nov 2016 02:08:00 -0500 0