https://medicaldevicecourses.com/members/asimbana/activity/mentions/ Activity feed mentioning asimbana. Fri, 24 Apr 2026 20:02:28 -0400 https://buddypress.org/?v= en-US 30 hourly 2 2a31448d90d7d45817ca381fecf6f739 https://medicaldevicecourses.com/activity/p/29497/ Wed, 11 Sep 2024 23:29:23 -0400 @asimbana , completely agree. I find it very interesting going through the comments and seeing a slight divide, in that many that are already out of college agree that more practical courses would be better, and some in college are…   Read more»

]]> 9e542d38d4c6a586e22ff7a820a48bc3 https://medicaldevicecourses.com/activity/p/15192/ Wed, 15 May 2019 19:03:51 -0400 I agree with @asimbana that ISO provides more flexibility with their definition “processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measuring. Whereas the FDA has a stricter definition of “results of…   Read more»

]]> 1d6c8fedf31ef0036f95294ec2d95435 https://medicaldevicecourses.com/activity/p/14833/ Wed, 15 May 2019 19:00:36 -0400 I agree with @julienneniuya and @asimbana that Verification is to confirm that design outputs equals the inputs. That the design numbers/specs set out are accomplished whereas with validation is the confirmation on the end user that the device meets the…   Read more»

]]> d6b312a5b3bc93caf77057155f7cccbd https://medicaldevicecourses.com/activity/p/13936/ Wed, 15 May 2019 17:09:39 -0400 I agree with previous posts like @asimbana mentions that validation is important to determine if device meets user needs and it’s intended use. I like @williamzembricki‘s comment “When in doubt, validate”. I agree that it is necessary for most cases…   Read more»

]]> 2433adcb9c020e961a58fcac60beff91 https://medicaldevicecourses.com/activity/p/13399/ Wed, 15 May 2019 17:04:35 -0400 I agree with @bb224 and @asimbana that for a medical device company of mid-size with 50 people and $10 million in revenue they should be an Inc so they have the ability to go public and spark some interest and…   Read more»

]]> a7dd432f5f4fa9d39be2cf86edce438e https://medicaldevicecourses.com/activity/p/13378/ Wed, 15 May 2019 17:04:25 -0400 I agree with @bb254 and @asimbana about the INC choice over LLC and would like to add more on the CONS. The biggest drawback is the double taxation (C Corp). Also, shareholders that control and own a significant amount, or…   Read more»

]]> 482b48b16e32b673c04cbd20a15ae99c https://medicaldevicecourses.com/activity/p/13236/ Wed, 15 May 2019 17:03:08 -0400 I echo the sentiments of others like @asimbana and @bb254 that QA/QC is necessary and is crucial to the success of products. Spending extra time and money and going through QA/QC processes/methods isn’t ideal, but it is necessary to lower…   Read more»

]]> 0496277e89904e81e1aed4fc2982804b https://medicaldevicecourses.com/activity/p/13230/ Wed, 15 May 2019 17:03:06 -0400 I agree with @asimbana, both departments have different objectives, which is why you’d find R&D and Quality on different ends. I think that they both have the right idea, and they are just doing their jobs, but it can be…   Read more»

]]> 8292ed690b17b6c83812c6b0b06efc21 https://medicaldevicecourses.com/activity/p/6588/ Sun, 25 Feb 2018 19:06:59 -0500 I agree with @asimbana that ISO provides more flexibility with their definition “processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measuring. Whereas the FDA has a stricter definition of “results of a process cannot be fully verified by subsequent inspection and test”. As…[Read more]

]]> 0 1ebbbf82219e43bcc2ea1a715815be6b https://medicaldevicecourses.com/activity/p/6105/ Sun, 04 Feb 2018 19:25:56 -0500 I agree with @julienneniuya and @asimbana that Verification is to confirm that design outputs equals the inputs. That the design numbers/specs set out are accomplished whereas with validation is the confirmation on the end user that the device meets the user needs. When researching industry validation processes, I came across a New York Times…[Read more]

]]> 0 822739a96f4f20d754f3c27bd8a90463 https://medicaldevicecourses.com/activity/p/4947/ Tue, 07 Nov 2017 00:34:11 -0500 I agree with previous posts like @asimbana mentions that validation is important to determine if device meets user needs and it’s intended use. I like @williamzembricki‘s comment “When in doubt, validate”. I agree that it is necessary for most cases especially with medical devices for validation to be done. Validation is key in determining and…[Read more]

]]> 0 84fe0fdc0c99d16c5448d00fd998523d https://medicaldevicecourses.com/activity/p/4071/ Fri, 13 Oct 2017 02:49:17 -0400 I agree with @bb224 and @asimbana that for a medical device company of mid-size with 50 people and $10 million in revenue they should be an Inc so they have the ability to go public and spark some interest and attract investors (VCs, etc). The company should be incorporated in Delaware since they have more favorable corporate and tax laws. As @thu…[Read more]

]]> 0 ea4190681b70fad374d60639254c153f https://medicaldevicecourses.com/activity/p/4040/ Tue, 10 Oct 2017 21:42:03 -0400 I agree with @bb254 and @asimbana about the INC choice over LLC and would like to add more on the CONS. The biggest drawback is the double taxation (C Corp). Also, shareholders that control and own a significant amount, or majority, of the corporation’s voting stock have a dominant voice in the management of the business in comparison to s…[Read more]

]]> 0 294eb90bedc9fa8412a3b55f4b2b8ab3 https://medicaldevicecourses.com/activity/p/3847/ Tue, 03 Oct 2017 00:45:39 -0400 I echo the sentiments of others like @asimbana and @bb254 that QA/QC is necessary and is crucial to the success of products. Spending extra time and money and going through QA/QC processes/methods isn’t ideal, but it is necessary to lower risk. For example in 2010 Johnson and Johnson underwent a quality control reorganization after both the House…[Read more]

]]> 0 59e2d105e7c51c8b34fb20f9bdc05801 https://medicaldevicecourses.com/activity/p/3836/ Mon, 02 Oct 2017 18:54:00 -0400 I agree with @asimbana, both departments have different objectives, which is why you’d find R&D and Quality on different ends. I think that they both have the right idea, and they are just doing their jobs, but it can be conflicting when it comes to the actual production and finalizing of products. These are the types of situations that should…[Read more]

]]> 0