Project #68315 - FDA Medical Device

 

Memorandum

 

 

 

 

Subject: FDA Medical Device Regulatory

 

  

 

To conclude your formal introduction to FDA-regulated medical device best practices, you are charged with a culminating experience that entails the development of two mini case reviews on US FDA CDRH approved medical device technologies. The first mini-case review will entail a succinct retrospective analysis of a class II or class III medical device submission that was recently cleared or approved for marketing by the US FDA CDRH. The second mini-case review will entail the creation of a succinct ‘forensic analysis’ of a previously market exempted, cleared or approved class I, class II or class III medical device that has been recently recalled.Please use the FDA website resource only (www.fda.gov) and click on medical devices on the menu bar. This will take you to the Center for Devices and Radiological Health (CDRH) web resource that includes medical device Approvals and Clearance and Recalls & Alerts that are located on the right hand side of the main page.

 

 

 

1. [45%] The contents of your retrospective analysis for a recently approved medical device should include:

 

- An Introduction Section that provides salient information on (15%)

 

o the medical device company who manufacture the technology

 

o the health care market need and targeted customers

 

o the underlying technology associated with the medical device performance

 

- section on General Controls information that the company provided the FDA

 

o company name and location, name of medical device, etc (5%)

 

- section on the Medical Device Submission route(10%)

 

o medical device classification taken

 

o medical device regulatory pathway taken

 

- section on FDA Clearance or Approval Response Letter (5%)

 

o salient features of the FDA response letter

 

- section of Reflection by budding BME 214 medical device designer (you)

 

o Insights Gained & Perspectives Formed (10%)

 

 

 

2. [45%] The contents of your forensic analysis on a recently recalled medical device should include:

 

- a Background section that describes (15%)

 

o the medical device company who manufacture the technology

 

o the health care market need and targeted customers

 

o the underlying technology associated with the medical device performance

 

- section on nature & circumstances associated with the Medical Device Recall (5%)

 

- a section on the company plans related to Corrective Actions warranted (5%)

 

- a section on the technical nature of the Failure Mode*(10%); See Intro FMEA below

 

- a final section on your Reflection as to how this device failure and subsequent recall may have been avoided or could be avoided in the future by better design (10%)

 

 

 

3. [10%] Format: Title Page with Name of Author, class associated with this task [BME214], project type (Retrospective Analysis of FDA Medical Device Applications); Date; Main Body: Length 3.5-4 pages; Times New Roman 12 Font; single space. Please include sub-headings as listed above.

 

 

 

 

* Failure Modes and Effects Analysis(FMEA) is a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. FMEA includes review of the following: Steps in the process Failure modes (What could go wrong?) Failure causes (Why would the failure happen? Failure effects (What would be the consequences of each failure?) Teams use FMEA to evaluate processes for possible failures and to prevent them by correcting the processes proactively rather than reacting to adverse events after failures have occurred.

Subject Medicine
Due By (Pacific Time) 04/29/2015 12:00 am
Report DMCA
TutorRating
pallavi

Chat Now!

out of 1971 reviews
More..
amosmm

Chat Now!

out of 766 reviews
More..
PhyzKyd

Chat Now!

out of 1164 reviews
More..
rajdeep77

Chat Now!

out of 721 reviews
More..
sctys

Chat Now!

out of 1600 reviews
More..
sharadgreen

Chat Now!

out of 770 reviews
More..
topnotcher

Chat Now!

out of 766 reviews
More..
XXXIAO

Chat Now!

out of 680 reviews
More..
All Rights Reserved. Copyright by AceMyHW.com - Copyright Policy