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[BME 214], project
type (Retrospective Analysis of FDA Medical Device Applications -Final Take Home); 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.
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