The author has carefully reviewed the document “IEC 62304:2006 Medical device software – Software life cycle processes" and defined the physical evidence recommended based upon this classification scheme. A second review of the complete list was conducted to ensure that the documents’ producers did not leave out a physical piece of evidence that a “reasonable person” would expect to find.  It could certainly be argued that if the document did not call it out then it is not recommended; however, if the document was used by an organization to improve its process, then it would make sense to recognize missing documents. Therefore, there are documents specified in this checklist that are implied by the standard, though not specifically called out in the document, and they are designated by an asterisk (*) throughout this checklist. These items are classified as suggested. If a document is called out more than one time, only the first reference is stipulated. If there are no new requirements or suggestions in a particular clause or sub-clause then the clause or sub-clause is omitted throughout sections 2-8.

There are occasional situations in which a procedure or document is not necessarily separate and could be contained within another document. For example, the “Data Base Requirements Document" could be a part of the Software Requirements Document". The author has called out these individual items separately to ensure that the organization does not overlook any facet of physical evidence. If the organization does not require a separate document, and an item can be a subset of another document or record, then this fact should be denoted in the detail section of the checklist for that item. This should be done in the form of a statement reflecting that the information for this document may be found in section XX of Document XYZ. If the organizational requirements do not call for this physical evidence for a particular project, this should also be denoted with a statement reflecting that this physical evidence is not recommended and why. The reasons for the evidence not being recommended should be clearly presented in this statement. Further details on this step are provided in the Detail Steps section of the introduction. The size of these documents could vary from paragraphs to volumes depending upon the size and complexity of the project or business requirements.

This “IEC 62304:2006” Information Technology - Medical Device Software - Sofrware Life Cycle Processes Checklist was prepared by analyzing each clause of this document for the key words that signify a:

• Procedure
• Plan
• Records
• Document (including Lists, Manuals, Reports, Scripts and Specifications)
• Audit
• Review

This checklist specifies evidence that is unique. After reviewing the completed document, the second review was conducted from a common sense “reasonable man” approach.  If a document or other piece of evidence appeared to be recommended, but was not called out in the document, then it is added with an asterisk (*) after its notation in the checklist. The information was transferred into checklist tables, based on the type of product or evidence.  

Using the Checklist
When a company is planning to use IEC 62304:2006 Information technology – Medical device software – Software life cycle processes” standard, the company should review the evidence checklist. If the company’s present process does not address an IEC 62304:2006 product, then this question should be asked: Is the evidence product recommended for the type of business of the company? If in the view of the company the evidence is not recommended, the rationale should be documented and inserted in the checklist and quality manual. This rationale should pass “the reasonable person rule.” If the evidence is recommended, plans should be prepared to address the missing item(s).

 Detail Steps
An organization should compare the proposed output of their organization against the checklist. In doing this, they will find one of five conditions that exist for each item listed in the checklist. The following five conditions and the actions required by these conditions are listed in the table below.

• Section 1: Introduction
• Section 2: Composites of all required and suggested “IEC 62304:2006 Medical Device Software - Software Life Cycle Processes'" evidence products. 
• Sections 3-8: Individual checklists for each evidence type.
• Section 9: “About the Authors”

Warranties and Liability
Software Engineering Process Technology (SEPT) makes no warranties implied or stated with respect to this checklist, and it is provided on an “as is” basis.  SEPT will have no liability for any indirect, incidental, special or consequential damages or any loss of revenue or profits arising under, or with respect to the use of this document.