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Medical Device Vigilance

An efficient and robust software module to register, track, maintain and analyze the complete events of device malfunction as well as the adverse events related to medical devices

Device manufacturers have a responsibility to implement an effective post-marketing surveillance system to ensure early identification of problems or risks and report these events to competent authorities and the Medical Device vigilance module of PvEdge helps them doing the same. To ensure the safety and effectiveness of medical devices and avoid the financial and legal liabilities associated with a device recall, medical device manufacturers began to assess and understand device risk during the product design stage of medical device development.

Medical device post-market surveillance is not only regulatory driven but should also be considered as a good business practice. It helps the manufacturer to obtain an understanding of the performance of the device once placed on the market and provides continuous feedback that enables manufacturers to maintain a high standard of product quality and consumer satisfaction. It also helps to minimize exposure arising from incidents through effective warning and product recall processes and procedures.

Why PvEdge?

Medical Device Vigilance Software module of Pharmacovigilance is a robust and full-fledged software to register, track, maintain and analyze the complete events of device malfunction as well as the adverse events related to medical devices.

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

Meeting regulatory compliance for device vigilance software

US FDA: Complaint for MedWatch electronic medical device reporting system and MDR regulation (21 CFR 803) containing the reporting for manufacturers, importers, and user facilities.

EU: Guidelines on A Medical Devices Vigilance System (MEDDEV 2.12-1 rev 8)

GHTF: Global Guidance for Adverse Event Reporting for Medical Device

Materiovigilance adverse event reporting form for CDSCO submissions.