Technical Documentation Reviews
Are you struggling to get your technical documentation to meet the requirements of the MDR and IVDR?
Our technical documentation review service provides flexible support by our expert team to help you evaluate and compile your existing documentation, including:
▪ Performing a gap assessment of your existing MDD or IVD compliant technical documentation
▪ Providing solutions to fill those gaps so that you can be confident submitting your documentation
We can also help with remediation if you have already made a submission and questions have come back.