If we act as your Representative, we can submit incident reports to Competent Authorities on your behalf.
Our in-depth knowledge of the European medical device market ensures that your vigilance procedures will always be up-to-date.
Our experienced consultants can help determine whether incidents are reportable and can ensure that final incident reports are completed on time. We can support you in compiling the Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN).
Read more in our Publication: Medical Device – Post-Market Surveillance and Vigilance