MEDICAL DEVICE COMPLAINT HANDLING 

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Minimize risk and enhance compliance for your product; ZebraSCI provides investigative testing and full medical device complaint handling programs.

The FDA defines “complaint” as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. The ISO 13485:2016 definition is very similar.

Proper Medical device complaint handling management is key to complying with regulatory requirements not only in the US, but around the world as well. In the EU, MEDDEV 2.12/1 outlines post-market surveillance activities for proper incident investigation and CAPA handling.

ZebraSCI’s medical device complaint handling services provide an effective and simple way of facilitating the management of your product complaints, leaving you free to concentrate on bringing new products to market. Our programs are designed around the structured and time-sensitive processing of your returns. By conducting the original technical investigation and feeding data back to you rapidly, we enable you to provide a fast response to your end-users and react to technical failure trends early on.

Our programs can be tailored to your exact requirements and typically include:

  • Product Decontamination

  • Specification Confirmation

  • Failure Analysis

  • Investigative Testing & Data Analysis
  • Independent Analysis & Reporting

  • Archiving & Retain Management

Device Testing
Device Testing
Device Testing

Complaint Handling Regulatory Guidelines

ZebraSci offers a complete portfolio of  solutions to comply with regulatory expectations for life cycle management of medical devices.  With a wealth of experience in the development, failure analysis and improvement of medical devices, our experienced team provides consultative support to help you ensure the safety of your devices.

  • 21CRF820 Medical Devices Quality System Regulation (QSR)

    • 21CFR820.198 Complaint Files

  • 21CFR211 CGMP for Finished Pharmaceutical Products

    • 21CFR211.198 Complaint Files

  • EUROPEAN COMMISSION DG Health and Consumers

    • MEDDEV 2.12-1, GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM

With our knowledge and experience in failure analysis, investigative laboratory testing and regulatory guidance’s, ZebraSci partners with our clients to mitigate the risks associated with commercializing medical devices.

Common Complaint Failure Modes