April 6, 2017 – Regulatory Compliance, Medical Device – Responsibilities: Process or Receive/Record/Review complaint information.
Ensure the accuracy and completeness of initial information from the Complaint Intake Forms or other complaint notification communications.
Enter/Update complaint information into complaint management software.
Initial determination if a product issue is considered a valid complaint based upon company’s definition. Evaluate complaints to determine whether an adverse event report/Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting (93/42/EEC) and any other worldwide regulatory requirements.