Medical Device Courses | jk299 | Activity https://medicaldevicecourses.com/members/jk299/activity/ Activity feed for jk299. Fri, 24 Apr 2026 22:39:12 -0400 https://buddypress.org/?v= en-US 30 hourly 2 f62dab506105f6fd75e791b22c5026b8 jk299 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11448/ Wed, 15 May 2019 16:45:03 -0400 I suppose it would depend on the sitution, if a stated specific agreement has to be met with legal implications and monatary value on the line then a written agreement is needed. However when other non legal binding or possible…   Read more»

]]> e9a7d5f89a63384cfe81739f7c24930d jk299 replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/11447/ Wed, 15 May 2019 16:45:03 -0400 Correct, this is to impose and ensure ethical manners in the busniness world, even though the intentions may be well it still may lye other intenetions. which may not be approbriate. However espically when taking one to dinner, I think…   Read more»

]]> 8cc3e927e11a38ebdc5c0bee9ef7af2c jk299 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11446/ Wed, 15 May 2019 16:45:02 -0400 This course has been a great one, that taught me the ins and outs of the medical devices and the logistics behind it. i enjoyed the course a lot and learned so much. This gave me an idea as to…   Read more»

]]> 45cf53361310e25d519b6e10d0b33f87 jk299 replied to the topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/11218/ Wed, 15 May 2019 16:43:01 -0400 I still like the matrix organization, as it induces proper work flow and opens the fied for the employess to get the job done. Ideally if you would want the goal of being larger company that works on multiple projects…   Read more»

]]> 49a09b5655ad818aecd1f3db81f8b1c1 jk299 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11217/ Wed, 15 May 2019 16:43:01 -0400 Well in the real world senerio you usually do not pick who you end up working with and it always best to work with those who have the right skill set to do the job and project needed. And these…   Read more»

]]> c9ced453b1c0749d2ef8ef2d352e9c68 jk299 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11216/ Wed, 15 May 2019 16:43:01 -0400 So the company I would like to be in is a matrix organization because a matrix organization is one that ” brings together employees and managers from different departments to work toward accomplishing a goal” it is a large sense…   Read more»

]]> d8aa994f0b14bdcbafd222501118b8bb jk299 replied to the topic "Manage Risk" - https://medicaldevicecourses.com/activity/p/11215/ Wed, 15 May 2019 16:43:00 -0400 I do feel, though that prediction is the very crucial to the risk Management, as mangers like employs who are proactive and can spot mistakes and risks early on before they happen. I say acceptance us lower because what does…   Read more»

]]> 7a61797c9d105aaf873dcc203a7b4ca7 jk299 replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11140/ Wed, 15 May 2019 16:40:14 -0400 Involving in risk analysis is a serious task, and often requires a large amount of personnel working simultaneously to properly analyze the associated risk. as such, workings in some companies if seen are those with computational modeling of risks and…   Read more»

]]> 6561ce7a0a7169a0b84ae0a304d3ad33 jk299 replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/11139/ Wed, 15 May 2019 16:40:14 -0400 I agree with the last one in the sense that companies should, if they don’t already do, perform risk analysis and risk management on the product all throughout the product lifecycle as a way to ensure the customer and the…   Read more»

]]> 576e0b9953974f7092541ff7d2dbbeeb jk299 replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/11137/ Wed, 15 May 2019 16:40:13 -0400 I agree, essentially it is this, that a company should do what it reasonability can to ensure all risks are assessed and ensure no negligence is done on the part of the company to put the users at risk. And…   Read more»

]]> 396592eaca7b18660165258789c50d6e jk299 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/11136/ Wed, 15 May 2019 16:40:12 -0400 Hello, Good point, they should be quite detailed and yet not overly complicated as to confuse the reader, it is essentially a form of management that is done to make sure tasks are on the way and are being done…   Read more»

]]> 77533144fe91c0dd4d85977376cb5a1d jk299 replied to the topic "Discussion Topic: Risk Management, Risk Analysis" - https://medicaldevicecourses.com/activity/p/11068/ Wed, 15 May 2019 16:39:36 -0400 A search revels “ISO 14971 is an ISO standard for the application of risk management to medical devices.The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 working with IEC/SC62A through Joint Working Group one…   Read more»

]]> f5cf3445eaecb8217b68babe25543764 jk299 replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11067/ Wed, 15 May 2019 16:39:36 -0400 The risk assessment can differ from various ways, they typically may have someone who is acquainted with the field but look an analyze the device from top to bottom, every inch to check from a technical side any associated risks,…   Read more»

]]> f90bff8af8281cf19deb8e6843203f30 jk299 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/11066/ Wed, 15 May 2019 16:39:35 -0400 Meeting minutes are import as a form of almost quality control for meetings; it’s a form of accountability and covering for everyone. As someone who is taking notes of recording the meeting can reference back to a specific date if…   Read more»

]]> f7e8664e3c3cb8998c6391adf1d8d05b jk299 replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/11065/ Wed, 15 May 2019 16:39:35 -0400 Hello, The meeting structure is very organized, with a moderator and someone taking notes to reference in later meetings who said what. It is essentially a time to get everyone in one room to work on and discuss the progress…   Read more»

]]> 2506dae4c45b3912ec91fdc1b10d7660 jk299 replied to the topic "Design Transfer and Challenges" - https://medicaldevicecourses.com/activity/p/10944/ Wed, 15 May 2019 16:38:10 -0400 for instacne, science protocols are subjected to change, there are disputed methods in the scinetific communinty for thr exact protocol of proecdures and expirments being used. Also in business the change is indictive of the accountingmethods used for the design…   Read more»

]]> ba7195093b7cf8615b9d71f1fae90e49 jk299 replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/10889/ Wed, 15 May 2019 16:37:35 -0400 this goes to validation vs verfiiction so from the regulatroy refrence site we have the following, “Validation is the process of checking whether the specification captures the customer’s needs, while verification is the process of checking that the software meets…   Read more»

]]> 482bf451fbe46e7a7412d61009d22e74 jk299 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10887/ Wed, 15 May 2019 16:37:34 -0400 Design inputs can be a wiede variety of notions, both physical and in the form of an implmented stragety like marketing inputs. A web search of design controls brings up the following ” Design controls designates the application of a…   Read more»

]]> ee3462f985f3b101764f5f6e67384252 jk299 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/10808/ Wed, 15 May 2019 16:36:46 -0400 So while the document is not nessarly exactly like a DHF, a document similar to it is needed. Since the an origin of this document is the Formal Design Control and Design History File (DHF) requirements which are parts of…   Read more»

]]> 7f49dffa61fc82445afb58ca67e194dd jk299 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/950/ Tue, 06 Dec 2016 00:36:26 -0500 I suppose it would depend on the sitution, if a stated specific agreement has to be met with legal implications and monatary value on the line then a written agreement is needed. However when other non legal binding or possible court appreences are in order and oral agreement is needed. I have known of some agreements to be recorded as well for…[Read more]

]]> 0 f8ee322699979ceb3c1a041ee4048b8e jk299 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/949/ Tue, 06 Dec 2016 00:32:02 -0500 Correct, this is to impose and ensure ethical manners in the busniness world, even though the intentions may be well it still may lye other intenetions. which may not be approbriate. However espically when taking one to dinner, I think it should be allowed to at least be able to pay for there partners dinner as well. This may lead to some strange…[Read more]

]]> 0 da3c9de62a3b7d53cff20355dc7fc15b jk299 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/948/ Tue, 06 Dec 2016 00:27:48 -0500 This course has been a great one, that taught me the ins and outs of the medical devices and the logistics behind it. i enjoyed the course a lot and learned so much. This gave me an idea as to the practical industrial aspect of biomedical engineering which is not tradationally taught in other classes, which makes this one invaluable and definetly…[Read more]

]]> 0 3110ea32fd7c50c58e0561ac9e25e7bc jk299 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/673/ Wed, 23 Nov 2016 16:55:50 -0500 I still like the matrix organization, as it induces proper work flow and opens the fied for the employess to get the job done. Ideally if you would want the goal of being larger company that works on multiple projects then this would be a best thing to do as it allows the right balance of leadership and science in a mutally beinfincal way for the…[Read more]

]]> 0 2b2e71c3df9fbf40dbc33ab2d098ecb1 jk299 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/672/ Wed, 23 Nov 2016 16:50:54 -0500 Well in the real world senerio you usually do not pick who you end up working with and it always best to work with those who have the right skill set to do the job and project needed. And these may not end up being your friends. In the professonal work enviroment some comprises have be made to get the project going and the work done. This includes…[Read more]

]]> 0 c3b940dc2a398e2a3bc5cac951517c31 jk299 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/671/ Wed, 23 Nov 2016 16:34:01 -0500 I do feel, though that prediction is the very crucial to the risk Management, as mangers like employs who are proactive and can spot mistakes and risks early on before they happen. I say acceptance us lower because what does it serve. Ok so the product has risk and an error, immediately think to fix the problem and mitigate the error in the best…[Read more]

]]> 0 71e9a581a604e69af35c7a0589ba3fca jk299 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/581/ Sun, 20 Nov 2016 20:58:10 -0500 Involving in risk analysis is a serious task, and often requires a large amount of personnel working simultaneously to properly analyze the associated risk. as such, workings in some companies if seen are those with computational modeling of risks and parameter values changing in stuff like survival analysis. Survival analysis is ” Survival…[Read more]

]]> 0 fb682bc42dd388ae09ca97605e6284f1 jk299 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/579/ Sun, 20 Nov 2016 20:50:13 -0500 I agree with the last one in the sense that companies should, if they don’t already do, perform risk analysis and risk management on the product all throughout the product lifecycle as a way to ensure the customer and the public that the product is safe, effective and practical. This would increase sales and increase confidence in the product.…[Read more]

]]> 0 254cbfff302a41bcf4b70690cfa1891d jk299 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/577/ Sun, 20 Nov 2016 20:44:11 -0500 I agree, essentially it is this, that a company should do what it reasonability can to ensure all risks are assessed and ensure no negligence is done on the part of the company to put the users at risk. And this should be done without the thought for cost as a mandatory step and due process that regulations and companies owe to the public. It is…[Read more]

]]> 0 ad2e76785b1756dcf7c36c2fa6fb4a4c jk299 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/576/ Sun, 20 Nov 2016 20:35:49 -0500 Hello,

Good point, they should be quite detailed and yet not overly complicated as to confuse the reader, it is essentially a form of management that is done to make sure tasks are on the way and are being done effectively. Project managers often use these to enhance and make an inference as to the progress of the projects being done. It is…[Read more]

]]> 0 013ae91c37cb31e4ff2a1cd4fa1b2bb7 jk299 replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/472/ Tue, 15 Nov 2016 01:47:11 -0500 A search revels
“ISO 14971 is an ISO standard for the application of risk management to medical devices.The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51”

this is a…[Read more]

]]> 0 b14cf1e67bc7eb168438cfb0377f1da2 jk299 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/471/ Tue, 15 Nov 2016 01:41:48 -0500 The risk assessment can differ from various ways, they typically may have someone who is acquainted with the field but look an analyze the device from top to bottom, every inch to check from a technical side any associated risks, even risks like, how will this device react with the body, will it make a reaction or cause one. Also the use of…[Read more]

]]> 0 6b7bebd1424773de719206e283befadc jk299 replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/470/ Tue, 15 Nov 2016 01:36:13 -0500 Meeting minutes are import as a form of almost quality control for meetings; it’s a form of accountability and covering for everyone. As someone who is taking notes of recording the meeting can reference back to a specific date if for instance, the boss wants to know who was in charge of this item. Or who suggested this idea. It is a form of b…[Read more]

]]> 0 c5fc9c2e6f72bd855e1e510896e2543e jk299 replied to the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/469/ Tue, 15 Nov 2016 01:31:43 -0500 Hello,

The meeting structure is very organized, with a moderator and someone taking notes to reference in later meetings who said what. It is essentially a time to get everyone in one room to work on and discuss the progress of the project and the necessary items that need to get done as well as the next steps and issues that arise. It has to do…[Read more]

]]> 0 2c1f353b92bd38ece88861af40d89b42 jk299 replied to the topic Design Transfer and Challenges in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/315/ Wed, 09 Nov 2016 23:26:29 -0500 for instacne, science protocols are subjected to change, there are disputed methods in the scinetific communinty for thr exact protocol of proecdures and expirments being used. Also in business the change is indictive of the accountingmethods used for the design transfer, for instance if the design and schematics of this product is moved to…[Read more]

]]> 0 7fae761700ec7e077cb16cd214098a7d jk299 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/237/ Mon, 07 Nov 2016 02:07:34 -0500 this goes to validation vs verfiiction

so from the regulatroy refrence site we have the following,

“Validation is the process of checking whether the specification captures the customer’s needs, while verification is the process of checking that the software meets the specification”

they are coupled in realtions just like QA VS QC but are…[Read more]

]]> 0 7997bc8827caf0f70c9ae62cc1fdcbdc jk299 replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/234/ Mon, 07 Nov 2016 02:02:16 -0500 Design inputs can be a wiede variety of notions, both physical and in the form of an implmented stragety like marketing inputs. A web search of design controls brings up the following

” Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to…[Read more]

]]> 0 41778a9a8f335ff0a91d36496aadb459 jk299 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/95/ Tue, 01 Nov 2016 18:48:07 -0400 So while the document is not nessarly exactly like a DHF, a document similar to it is needed. Since the an origin of this document is the Formal Design Control and Design History File (DHF) requirements which are parts of GMPs that were instituted and set by the FDA in 1996-1997. Similar design controls are required in europe. Europe does…[Read more]

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