PvEdge Global Medical Device vigilance software

The purpose of the Medical Device Vigilance System is to improve the protection of the health and safety of patients, healthcare professionals, and other users by reducing the likelihood of the reoccurrence of incidents related to the use of a medical device.

Chapter VII of the EU MDR and IVDR, articles 87 – 92 and 82-87 respectively comprise the Medical Device Vigilance System.

The guidance applicable for the same is Meddev 2.12-1, Rev 8. It is also a requirement under?EN ISO 13485, Clause 8.2.3 (Reporting to Regulatory Authority).

The Medical Device Vigilance software module of PvEdge manages:

• Incident reports including malfunctions
• Captures all relevant information as per medical device reporting (MDR), assigning them a unique Manufacturer Report Number, meeting all documentation, and recordkeeping requirements
• Records incident information, device attribution analysis, and evaluations/investigations results, allowing easy and timely access and retrieval of data
• Helps in the generation of various reports for submission to different regulatory authorities around the world

Do connect with us for a Demo

[email protected]/[email protected]