J
I am currently updating our controlled forms relating to Vigilance in accordance with the updated MEDDEV (rev 5). I have access to the standard form for Manufacturers to Report an Incident to the National Competent Authority (section 10.3 of the MEDDEV). However I wondered if anyone had forms they could share detailing
1. Initial Incident reporting that can be completed by the hospital or completed internally if an event is telephoned/faxed/emailed through - this would detail relevant facts about the incident.
2. An Adverse Incident checklist
Many thanks
1. Initial Incident reporting that can be completed by the hospital or completed internally if an event is telephoned/faxed/emailed through - this would detail relevant facts about the incident.
2. An Adverse Incident checklist
Many thanks

