Medical Device Courses | limalo | Activity https://medicaldevicecourses.com/members/limalo/activity/ Activity feed for limalo. Sat, 25 Apr 2026 02:56:45 -0400 https://buddypress.org/?v= en-US 30 hourly 2 607c8e4ec6066494b64eed7bb20d0ebd limalo replied to the topic "Significant or non-significant risk" - https://medicaldevicecourses.com/activity/p/11582/ Wed, 15 May 2019 16:47:51 -0400 Basically significant risk devices are to be use in supporting human life and present a potential risk to the patient’s health. The potential harm to subjects could be life-threatening, could result in permanent impairment of a body function or permanent…   Read more»

]]> 9c69925df8dcac7decbc753d877a533e limalo replied to the topic "Discussion Topic: To trial or not to trial" - https://medicaldevicecourses.com/activity/p/11568/ Wed, 15 May 2019 16:47:43 -0400 Design validation ensures that devices conform to defined user needs and the intended use stated in the design input. I believe a diagnostic microscope has no risk on people therefore there is no need for clinical trial. An implantable bone…   Read more»

]]> 2c2934e00cac61ed6e096c6729d9d4e2 limalo replied to the topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/11515/ Wed, 15 May 2019 16:45:35 -0400 I work in a matrix organization, where employees may report to many managers, for example in my case I work as design engineer in a functional department sometimes the company gets a project that needs a design engineer to assist…   Read more»

]]> 684084092f5edcdf1fc7256d0e2ed63e limalo replied to the topic "Discussion Topic: Share your project management experience" - https://medicaldevicecourses.com/activity/p/11481/ Wed, 15 May 2019 16:45:19 -0400 I work for a class I and II medical device company that carries out development, manufacturing and marketing of implant-based dental restorations. Unfortunately we do not have a well developed project management system, in other words we don’t have project…   Read more»

]]> eafd7436bd039f6f77e9863adbf89397 limalo posted a new topic "Difference" - https://medicaldevicecourses.com/activity/p/10431/ Wed, 15 May 2019 16:33:31 -0400 What do you think is the difference between a project manager and a clinical project manager

]]> d3cc4826332e5f77f0a0086e48eb5bca limalo posted a new topic "Project Manager Skills" - https://medicaldevicecourses.com/activity/p/10426/ Wed, 15 May 2019 16:33:29 -0400 What do you think is one skill a project manager needs to succeed?

]]> 4f050fd168ce94d678b3653148ec5907 limalo replied to the topic Significant or non-significant risk in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1184/ Fri, 27 Jan 2017 03:45:25 -0500 Basically significant risk devices are to be use in supporting human life and present a potential risk to the patient’s health. The potential harm to subjects could be life-threatening, could result in permanent impairment of a body function or permanent damage to the body structure. for example dental implants which required clinical trials. In…[Read more]

]]> 0 67a322a974299f1e13a418a7882329fb limalo started the topic Difference in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1155/ Thu, 26 Jan 2017 03:47:27 -0500 What do you think is the difference between a project manager and a clinical project manager

]]> 0 ec10f4bea5485b0d7a517c483c41aea7 limalo replied to the topic Discussion Topic: To trial or not to trial in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1152/ Thu, 26 Jan 2017 03:40:44 -0500 Design validation ensures that devices conform to defined user needs and the intended use stated in the design input. I believe a diagnostic microscope has no risk on people therefore there is no need for clinical trial. An implantable bone plate is considered class III medical device meaning highly risk for patients so we must perform clinical…[Read more]

]]> 0 9059cedbe8754431571e1df141ccafee limalo replied to the topic Discussion Topic: State of your Organization in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1071/ Sun, 22 Jan 2017 20:03:11 -0500 I work in a matrix organization, where employees may report to many managers, for example in my case I work as design engineer in a functional department sometimes the company gets a project that needs a design engineer to assist the “project manager” (senior process Engineer because we do not have PMs) on certain tasks. I may be assigned to the…[Read more]

]]> 0 f9db9d828d944e3436bfacd23a3c94e4 limalo replied to the topic Discussion Topic: Share your project management experience in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1022/ Sat, 21 Jan 2017 18:35:19 -0500 I work for a class I and II medical device company that carries out development, manufacturing and marketing of implant-based dental restorations. Unfortunately we do not have a well developed project management system, in other words we don’t have project managers, usually senior process engineers take the role and run the projects, to keep track…[Read more]

]]> 0 defc9bb200482db70df915a525b7af66 limalo started the topic Project Manager Skills in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1020/ Sat, 21 Jan 2017 18:25:51 -0500 What do you think is one skill a project manager needs to succeed?

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