Complaint Handling for Post Market Activities

Do you know the importance of complaints? Its legal implications? Impact on Post Market Surveillance? Complaint Handling play an important role in the device industry and is a regulatory requirement as well as a risk-reduction imperative. Thus, it is extremely important to manage and resolve complaints as per guidelines and standards of regulatory bodies.

IZiel helps companies to develop the mechanism of post-market activities. IZiel assist the companies to document the complaints handling process, help you to understand the objectives of compliant handling within the context of overall Quality System and  Corrective and Preventive Action (CAPA) subsystem.

IZiel Approach for Detailed Complaint Handling  

IZiel would adopt & implement these steps to help you with compliant handling –

  • Establishing Complaint Handling System as per legal requirements of ISO 13485, MDR and US regulation for Medical devices (CFR 820)
  • Implementation and support to customer for a particular period
  • Investigation Training
  • Root Cause finding and decision making for corrective and preventive action (CAPA)
  • Developing process for customer feedback and incorporating changes for product improvement.
  • Establish Complaints Handling System –
    • Develop procedures for receiving, reviewing, and evaluating complaints by incorporating a formally designated department that ensures:
    • Process complaints in a uniform and timely manner 
    • Documentation of oral complaints upon receipt
  • Initial Review and Evaluation –
    • Guidance to determine whether an investigation is necessary through reviews and evaluation of complaints.
    • If no investigation is needed, then help to document:
          • Reason
          • Name of responsible individual
  • Investigation of Failures –
  • Guidance & Training to assist companies to conduct thorough review, evaluation and investigation of alleged complaints involving possible failure of a device or labelling/packaging to meet any of its specifications.
  • IZiel can assist with CAPA, as no investigation is required for recurring similar complaints.
  • Medical Device Reporting  –
    • Evaluation to determine if failure investigation and/or a medical device report (MDR) is required
    • IZiel can help you maintain data in a separate portion of the complaint files or be otherwise clearly identified.
    • Assist in keeping additional records of investigation in view of:
          • Whether device failed to meet specifications
          • Whether device was used for treatment/diagnosis
          • Relationship, if any, of device to reported incident/adverse event
  • Records –
    • IZiel will help you maintain records of investigations in consideration to below details, which is a must while complaint handling:
          • Device name
          • Date of receipt of complain
          • Unique Device Identifier (UDI), Universal Product Code (UPC), and/or any other device identification(s) (e.g., control/batch/lot number(s))
          • Name, address, and phone number of complainant(s)
          • Nature/details of the complaint
          • Results and dates of investigation
          • Corrective action taken
          • Reply/response to complainant

IZiel work with medical device companies to effectively manage Complaints Handling, thereby, help you provide better, safer, more effective & quality product.