Evaluation (Validation and Verification) - Medical Device Design: Innovation from Concept to Market - page 249

Identify sources for search

Literature identified from search

Literature excluded: give reasons

Remaining literature reviewed and assessed

Data assimilated for:
-Substantial equivalence
-Device performance
-Device safety

Report written
Copies of relevant literature included
Signed off by qualified person

File in DHF/technical file

Figure 9.25
Literature review methodology (adapted from EC, 2009 ).

Figure 9.25 illustrates that potential literature needs to be found, selected, and analyzed.
Potential sources for information are varied. There are several learned publication search
engines for scientific literature:

- Google Scholar: http://scholar.google.com
- Medline: http://www.ncbi.nlm.nih.gov/pubmed/
- OVID: http://ovidsp.ovid.com/
- COCHRANE register of clinical studies: http://summaries.cochrane.org/

You will be able to see the abstract of the paper but unfortunately you will need to have an
account with the relevant publisher to obtain a full paper. However, if you work with a local
university they may have access via an educational license. In most cases the abstract is good
enough to make some selection of the papers you really want access to.

Obviously standards are an important port of call, but registers of notices and recalls are
equally valid (see Table 9.17 ).

Each of the search engines will require keywords for the search. You need to think of these
carefully; also, you will have to write them down as a record of your search.

For substantial equivalence the 510(k) database is of great value.

9.7.2 Format for Literature Review
As with all we have seen so far the best way to approach this is to have a standard pro forma.
Figure 9.26 is an example of a pro forma that would meet MEDDEV 2.7.1 rev 3, but also
provides the evidence for any FDA application.