Evaluation (Validation and Verification) - Medical Device Design: Innovation from Concept to Market - page 250

Table 9.17: Example Medical Device Recalls and Incidents Databases

IRIS - Australia's medical incidence database http://www.tga.gov.au/safety/problem-device-iris.htm

MAUDE - FDA database of manufacturers'
experiences

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfmaude/search.cfm

Medical device databases (FDA) http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/Databases/default.htm

Clinical Evaluation Literature review
Product Details Part Number

Title

Evaluation details Name

Date

Summary:

Approved by:
Signature Date:

1. Methodology:
2. Outputs:
3. Analysis:
Substantial Equivalence
Device performance
Device Safety

Figure 9.26
A typical literature review pro forma and sections.

Methodology : This section describes how the literature search was conducted and over what
period it was undertaken. It should contain the names of the search engines used and the
associated keywords and criteria. It should state the criteria for exclusion or the justification
for inclusion of any identified sources into the main review. It is useful to attach an unedited
search result in an appendix.

Outputs : This section should contain a copy of the documents identified.

Analysis : This is the section where you look at the publications and identify any recurring
issues, any areas of good practice, and any things to avoid. Group your analysis under the
following three disciplines irrespective of the source of the information:

- evidence for substantial equivalence;

- evidence that your device will perform as intended;

- evidence that your device is safe to use.