Medical Device Courses | pt58 | Activity https://medicaldevicecourses.com/members/pt58/activity/ Activity feed for pt58. Fri, 24 Apr 2026 20:47:02 -0400 https://buddypress.org/?v= en-US 30 hourly 2 c9996da07c8f6b4c33b06076c39a2564 pt58 replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/11389/ Wed, 15 May 2019 16:44:30 -0400 Almost all companies have an ethics/gift-giving policy in place. In these policies some of them allow you to take a client to a business dinner as long as it clearly business and not personal. These policies are in place to…   Read more»

]]> 0c05e632b2f2b5db7faa6373467e2212 pt58 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11388/ Wed, 15 May 2019 16:44:30 -0400 This course provides valuable insight to what is expected in the medical device industry. As someone who has taken all of Dr. Simons courses I can honestly say these courses prepares you for almost every little situation, no matter department…   Read more»

]]> 2d0d7a4ddce28c5848d139098856f05f pt58 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11387/ Wed, 15 May 2019 16:44:29 -0400 “Despite popular belief, oral contracts are enforceable. They usually are not in your best interests, and end in a “he said, she said” battle. But as long as there is enough evidence, a court will enforce an oral agreement. However,…   Read more»

]]> f15956df16869c87c802d045d230f343 pt58 replied to the topic "Organizational Behavior Management" - https://medicaldevicecourses.com/activity/p/11265/ Wed, 15 May 2019 16:43:28 -0400 I think being able to recognize this for your employees is a skill that is absolutely necessary in the hiring process when considering someone for a management position. Your manager should be able to see where you as an employee…   Read more»

]]> 877768bf04e7e98dab06884a32447e86 pt58 replied to the topic "Organizational structure and Culture both leading to project success?" - https://medicaldevicecourses.com/activity/p/11264/ Wed, 15 May 2019 16:43:27 -0400 I agree organization does influence company culture to an extent. However, I do think work culture is a big part of retaining employees. You want your company to do well overall and employee satisfaction can be essential to their individual…   Read more»

]]> f28366a0abf0be0597c5b39c05f9ee8b pt58 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11263/ Wed, 15 May 2019 16:43:27 -0400 Functional, project-based, and matrix organizations all have their individual advantages and disadvantages, as discussed per this week’s lecture. Most of you seem to prefer a Matrix structure. In my opinion a Matrix structure is great but it puts a lot…   Read more»

]]> 142c894c4afe95cdf89bb17590fd1abf pt58 replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/11106/ Wed, 15 May 2019 16:39:57 -0400 Our company offers several videos and training sessions that come with our product. The Training courses are, in my opinion, the best way to properly relay the information required so that the intended user applies the device in its intended…   Read more»

]]> 8cee5322e8179257c667979823b6f212 pt58 replied to the topic "Usability Risk Analysis" - https://medicaldevicecourses.com/activity/p/11105/ Wed, 15 May 2019 16:39:57 -0400 I think it is important to look at risk from several different methods. My company uses a Risk Management Summary, Failure mode, effects and criticality analysis, Process Failure Mode Effects Analysis, and Design Failure Mode and Effect Analysis for our…   Read more»

]]> 8834f890238f1404a0687fdd228e7824 pt58 replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11103/ Wed, 15 May 2019 16:39:56 -0400 In the position I am currently in I do a lot of Risk Analysis. This usually stems from investigations that open up when we are faced with a high failure rate for a particular non-conforming component. When doing the investigation…   Read more»

]]> ad0d71555e9f1846bd9b1e5e8c1966d7 pt58 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/11082/ Wed, 15 May 2019 16:39:44 -0400 The two common tools for project management schedule development are the Gantt and PERT chart. Both of these are great resources for planning and displaying the critical path of a project, however, they have their differences. In the simplest form…   Read more»

]]> b008dae344982ed431294a04229c3952 pt58 replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/11081/ Wed, 15 May 2019 16:39:44 -0400 I do agree with you “Reviews can be formal or informal, require a well-prepared agenda, and can last hours, days, or even a few weeks.” However, this is not always the case. At the company I am currently at we…   Read more»

]]> 7baedc5dc60d624d44242725a3e2a8e4 pt58 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/11079/ Wed, 15 May 2019 16:39:43 -0400 Meeting minutes are used as documentation so that any attendee, or persons not present, that looks at this document can understand the basics of what was discussed and reviewed during that meeting. In most companies there will be an SOP…   Read more»

]]> c4966a54455afe6469142dbf94e2bae9 pt58 replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/10848/ Wed, 15 May 2019 16:37:08 -0400 Like most of you mentioned before Validation and Verification are similar but the are not the same. In the verification process you are asking yourself “Did I make this product correctly”. This means you are matching if the product meets…   Read more»

]]> 93bf6941cde50e6ea6b2598eb05ca56a pt58 replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/10845/ Wed, 15 May 2019 16:37:07 -0400 Unless your product has already been on the market, the FDA will not allow you to take your product to market if your Design Controls are not deemed safe and effective. Design controls are documented, objective evidence you establish throughout…   Read more»

]]> 5b510484e0c5f33bee7334ff65edf031 pt58 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/10810/ Wed, 15 May 2019 16:36:47 -0400 “The DHF is mandated by the U.S. FDA, and describes a product through its development cycle, under Design Control, with its output being the DMR (Device Master Record) which defines the product as currently marketed. However, the EU (European Union)…   Read more»

]]> 878887c324ab95f2abb058fb33d73759 pt58 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/887/ Sun, 04 Dec 2016 18:41:44 -0500 Almost all companies have an ethics/gift-giving policy in place. In these policies some of them allow you to take a client to a business dinner as long as it clearly business and not personal. These policies are in place to protect the company from a bribery law suit. Take for example a renowned doctor, you can take him to dinner to discuss your…[Read more]

]]> 0 5cc19a26f905131521012f2e65c8c7ee pt58 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/886/ Sun, 04 Dec 2016 18:20:38 -0500 This course provides valuable insight to what is expected in the medical device industry. As someone who has taken all of Dr. Simons courses I can honestly say these courses prepares you for almost every little situation, no matter department or positon. The group studies, although made up, embody real stations that arise and allow you to work…[Read more]

]]> 0 a1e079696457e8e5874b5d1fdfb0da0c pt58 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/885/ Sun, 04 Dec 2016 17:43:01 -0500 “Despite popular belief, oral contracts are enforceable. They usually are not in your best interests, and end in a “he said, she said” battle. But as long as there is enough evidence, a court will enforce an oral agreement. However, there is one particular exception to this rule, and it’s called the Statute of Frauds.”
Statute of Frauds are cer…[Read more]

]]> 0 e1ebdb85b5a65adf0bae171763b69b4b pt58 replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/735/ Sun, 27 Nov 2016 16:53:34 -0500 I think being able to recognize this for your employees is a skill that is absolutely necessary in the hiring process when considering someone for a management position. Your manager should be able to see where you as an employee excel, hone your skills, and drive you further.

I also think it’s something that should be closely looked at when d…[Read more]

]]> 0 5c925e14169e91f85cbe9180d9e53a60 pt58 replied to the topic Organizational structure and Culture both leading to project success? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/734/ Sun, 27 Nov 2016 16:33:46 -0500 I agree organization does influence company culture to an extent. However, I do think work culture is a big part of retaining employees. You want your company to do well overall and employee satisfaction can be essential to their individual output. I have definitely seen both sides of the spectrum, I worked for a company that had a very welcoming…[Read more]

]]> 0 d7c810ff188883ab21400e5edb4d7441 pt58 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/733/ Sun, 27 Nov 2016 16:03:58 -0500 Functional, project-based, and matrix organizations all have their individual advantages and disadvantages, as discussed per this week’s lecture. Most of you seem to prefer a Matrix structure. In my opinion a Matrix structure is great but it puts a lot more pressure on the staff. As discussed you have two bosses. This type of architect can be h…[Read more]

]]> 0 540600f1a9d4ffebb14eb5d3438b344f pt58 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/526/ Fri, 18 Nov 2016 01:20:44 -0500 Our company offers several videos and training sessions that come with our product. The Training courses are, in my opinion, the best way to properly relay the information required so that the intended user applies the device in its intended use. Now of course you can’t train physically everyone but that is why the videos are available. The v…[Read more]

]]> 0 99e4e54d9fdad863c8e5719ab749e4c7 pt58 replied to the topic Usability Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/525/ Fri, 18 Nov 2016 01:01:28 -0500 I think it is important to look at risk from several different methods. My company uses a Risk Management Summary, Failure mode, effects and criticality analysis, Process Failure Mode Effects Analysis, and Design Failure Mode and Effect Analysis for our products. A combined view of all these quality system documents really help most engineers wrap…[Read more]

]]> 0 25411267c6edfac06cdb04bf746239ce pt58 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/523/ Fri, 18 Nov 2016 00:49:45 -0500 In the position I am currently in I do a lot of Risk Analysis. This usually stems from investigations that open up when we are faced with a high failure rate for a particular non-conforming component. When doing the investigation there are several methods one can use to get to the root cause of the problem. This can include several different…[Read more]

]]> 0 ff4e387c1adedb837e6365fb51ebd195 pt58 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/495/ Tue, 15 Nov 2016 21:43:01 -0500 The two common tools for project management schedule development are the Gantt and PERT chart. Both of these are great resources for planning and displaying the critical path of a project, however, they have their differences. In the simplest form A Gantt chart is basically a bar chart and a PERT chart is a flow chart. The Gantt allows you to view…[Read more]

]]> 0 165ed4c65bd63c34cf1e32c0f3dd562a pt58 replied to the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/494/ Tue, 15 Nov 2016 21:16:02 -0500 I do agree with you “Reviews can be formal or informal, require a well-prepared agenda, and can last hours, days, or even a few weeks.” However, this is not always the case. At the company I am currently at we have something called out in our design review SOP called an abbreviated design review. This type of review is usually only one or two mee…[Read more]

]]> 0 ae191cad2d6c9e602f857f2130f289cc pt58 replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/492/ Tue, 15 Nov 2016 21:02:07 -0500 Meeting minutes are used as documentation so that any attendee, or persons not present, that looks at this document can understand the basics of what was discussed and reviewed during that meeting. In most companies there will be an SOP for all general Meeting Minutes (which will usually include: general instruction and a boiler plate template for…[Read more]

]]> 0 5d04189584a7aaf395358ae5205a4c0f pt58 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/174/ Sat, 05 Nov 2016 19:18:26 -0400 Like most of you mentioned before Validation and Verification are similar but the are not the same. In the verification process you are asking yourself “Did I make this product correctly”. This means you are matching if the product meets the requirements and specifications and functions as necessary. Whereas in the validation process you are…[Read more]

]]> 0 1c727d48d7c4736028d40613988d9d48 pt58 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/171/ Sat, 05 Nov 2016 19:10:26 -0400 Unless your product has already been on the market, the FDA will not allow you to take your product to market if your Design Controls are not deemed safe and effective. Design controls are documented, objective evidence you establish throughout the product development process to prove your device is safe and effective. There is almost no way to…[Read more]

]]> 0 4f330ff9c6112e16e478595ade42e0f7 pt58 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/99/ Wed, 02 Nov 2016 02:05:25 -0400 “The DHF is mandated by the U.S. FDA, and describes a product through its development cycle, under Design Control, with its output being the DMR (Device Master Record) which defines the product as currently marketed. However, the EU (European Union) under the Medical Device Directive (MDD; EU Council Directive 93/42/EEC) and for CE-Marking, r…[Read more]

]]> 0