FDA issued a draft guidance for comment: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Contains Nonbinding Recommendations Draft – Not for Implementation Equivalence through Performance Criteria. The outline shows a Section 17 for software information. The outline can be viewed here.Read More
Remote Webmeeting Assessments
SoftwareCPR can provide remote offsite assessments to support virtual offices. Our consultants can utilize webmeeting tools to walk your teams through assessments such as:
