Medical Device Courses | mah52 | Activity https://medicaldevicecourses.com/members/mah52/activity/ Activity feed for mah52. Sat, 16 May 2026 12:13:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 2d0fa9996601edd663af2b464cfba18e mah52 replied to the topic "New Medical Device Project" - https://medicaldevicecourses.com/activity/p/14787/ Wed, 15 May 2019 19:00:03 -0400 I worked on a project to develop a needle that when used by the patient “Does not hurt as much”. That was the user requirement. So in order to asses what that meant or how to change that into product…   Read more»

]]> ddd999db5a8987905dbe4a1e47d47178 mah52 posted a new topic "Does Product Classification also depend on the Material of the Product used?" - https://medicaldevicecourses.com/activity/p/10637/ Wed, 15 May 2019 16:35:10 -0400 Suppose that you have a company that makes plastic syringes out of plastic A were to decide “Hey Plastic B is much cheaper lets use that instead”. Would the product classification change? Would there be a need for a PMA…   Read more»

]]> 818426c79bb36141cdb64f6de5b49a80 mah52 started the topic Does Product Classification also depend on the Material of the Product used? in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6047/ Thu, 01 Feb 2018 18:06:36 -0500 Suppose that you have a company that makes plastic syringes out of plastic A were to decide “Hey Plastic B is much cheaper lets use that instead”. Would the product classification change? Would there be a need for a PMA assuming this new Plastic B was never used before? Or could the company just classify it as a class 2 justifying that there are…[Read more]

]]> 0 9755174ed5a183482a0c07cc6817903c mah52 replied to the topic New Medical Device Project in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6046/ Thu, 01 Feb 2018 17:46:16 -0500 I worked on a project to develop a needle that when used by the patient “Does not hurt as much”. That was the user requirement. So in order to asses what that meant or how to change that into product requirement the team sat with the medical affairs team and came to an agreement. Pain is associated with nerve simulation. Therefore the needle had…[Read more]

]]> 0 b512fb67fd9d558cffa4ac80352f90dd mah52 became a registered member https://medicaldevicecourses.com/activity/p/6029/ Wed, 31 Jan 2018 20:01:35 -0500 0