https://medicaldevicecourses.com/members/ts353/activity/ Activity feed for ts353. Fri, 24 Apr 2026 20:47:02 -0400 https://buddypress.org/?v= en-US 30 hourly 2 9d31881720ee5d6315916b56d02fff99 https://medicaldevicecourses.com/activity/p/11199/ Wed, 15 May 2019 16:40:56 -0400 Risk identification and assessment can extend towards to human factors as well. The following are a few Devices used in an improper manner. Devices not manufactured and developed with appropriate specifications. Lack of user-friendliness. In addition to identification, the time…   Read more»

]]> bc747411ad093662c484e25d7267eead https://medicaldevicecourses.com/activity/p/11198/ Wed, 15 May 2019 16:40:55 -0400 According to an article, Summing the factors of all individual hazards to determine their cumulative effect is reasonably valid assuming all hazards occur simultaneously or within a short enough period that their negative effects (i.e., injuries) would, in fact, be…   Read more»

]]> 62073065382e0b63d7486b6510c2396d https://medicaldevicecourses.com/activity/p/11197/ Wed, 15 May 2019 16:40:55 -0400 Risk Management is the process of identifying, analyzing and responding to risk factors throughout the life of a project and in the best interests of its objectives. Proper risk management implies control of possible future events and is proactive rather…   Read more»

]]> b426031de2b2d18932d58dc21c3ff164 https://medicaldevicecourses.com/activity/p/10974/ Wed, 15 May 2019 16:38:27 -0400 Verification and Validation go hand in hand. They cover every phase of product development and it is always considered from the very beginning. Material performance, Package quality tests, Bio compatibility of materials, Sterilization tests are the most commonly performed tests….   Read more»

]]> ae646779ca557d9dade3583f170d9fad https://medicaldevicecourses.com/activity/p/10938/ Wed, 15 May 2019 16:38:07 -0400 A Design Transfer Procedure makes sure of mishaps do not occur during the transfer process. The procedure is typically overseen by the medical device company’s management. Design Change Procedures must dovetail with the Design Transfer Procedure to make sure the…   Read more»

]]> 2302fe97c8a13dfb83e016cc261e9fea https://medicaldevicecourses.com/activity/p/10936/ Wed, 15 May 2019 16:38:06 -0400 I would like to mention about EAP program, which stands for EXPEDITED ACCESS PATHWAY. It basically to aid and benefit patients who have not met their medical need, due to criteria issues. This program provides the following: 1. It’s main…   Read more»

]]> 89481fc131d6d9a3a3b6b9322aa1a160 https://medicaldevicecourses.com/activity/p/652/ Tue, 22 Nov 2016 15:33:36 -0500 Risk identification and assessment can extend towards to human factors as well. The following are a few
Devices used in an improper manner.
Devices not manufactured and developed with appropriate specifications.
Lack of user-friendliness.
In addition to identification, the time period for risk is as long as the product or the device is active.…[Read more]

]]> 0 f4b3720f56182696f8379646136d9098 https://medicaldevicecourses.com/activity/p/651/ Tue, 22 Nov 2016 15:20:46 -0500 According to an article, Summing the factors of all individual hazards to determine their cumulative effect is reasonably valid assuming all hazards occur simultaneously or within a short enough period that their negative effects (i.e., injuries) would, in fact, be cumulative. Based on the critical factors associated with summing the severity of…[Read more]

]]> 0 1d76a3be6e75fcf465709e261c07a4e9 https://medicaldevicecourses.com/activity/p/650/ Tue, 22 Nov 2016 15:15:13 -0500 Risk Management is the process of identifying, analyzing and responding to risk factors throughout the life of a project and in the best interests of its objectives.
Proper risk management implies control of possible future events and is proactive rather than reactive.
The acceptance or non-acceptance of a risk is usually dependent on the project…[Read more]

]]> 0 cd872287725200a36e69bb6721cfc6a4 https://medicaldevicecourses.com/activity/p/352/ Fri, 11 Nov 2016 20:09:14 -0500 Verification and Validation go hand in hand. They cover every phase of product development and it is always considered from the very beginning.
Material performance, Package quality tests, Bio compatibility of materials, Sterilization tests are the most commonly performed tests. After the tests are conducted, inspection and analyses is carried…[Read more]

]]> 0 bcb99673c6ae375d1e1c141aa2b23d92 https://medicaldevicecourses.com/activity/p/305/ Wed, 09 Nov 2016 21:43:28 -0500 A Design Transfer Procedure makes sure of mishaps do not occur during the transfer process. The procedure is typically overseen by the medical device company’s management.
Design Change Procedures must dovetail with the Design Transfer Procedure to make sure the correct information is provided to the company’s management staff in the pro…[Read more]

]]> 0 d588709671e5f618a04563ce7375c471 https://medicaldevicecourses.com/activity/p/304/ Wed, 09 Nov 2016 21:43:28 -0500 A Design Transfer Procedure makes sure of mishaps do not occur during the transfer process. The procedure is typically overseen by the medical device company’s management.
Design Change Procedures must dovetail with the Design Transfer Procedure to make sure the correct information is provided to the company’s management staff in the pro…[Read more]

]]> 0 ae6aa340102b10e9550c911830de1a96 https://medicaldevicecourses.com/activity/p/302/ Wed, 09 Nov 2016 21:37:41 -0500 I would like to mention about EAP program, which stands for EXPEDITED ACCESS PATHWAY. It basically to aid and benefit patients who have not met their medical need, due to criteria issues. This program provides the following:
1. It’s main purpose is to treat irreversible disease ad life threatening conditions.
2.It clears way to new upcoming…[Read more]

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