Kapstone’s Medical Device Compliance Program

Regulatory bodies in the US and EU expect that medical device companies will develop robust compliance programs to help them detect, prevent, and remedy any non-compliant activity. Without a compliance program, your company opens itself up to risk, costly remediation, and even regulatory consequences. Kapstone can help you create and maintain an effective compliance program that minimizes cost while maintaining your rigorous standards of quality.


The Benefits of a Medical Device Compliance Program:

  • Ensure device safety for patients
  • Establish tracing protocols
  • Conduct management reviews
  • Prepare for quality audits
  • Secure approval from regulatory bodies

Remediating Common Medical Device Compliance Issues


CAPA, or Corrective and Preventive Action procedures, are a legally required component of medical device compliance.

Under CAPA regulations, your organization is responsible for creating and maintaining procedures that: 

  • Analyze all data sources to identify potential nonconformities or other quality issues
  • Are prepared to investigate the causes of nonconformities
  • Can identify the actions needed to remedy nonconformities and prevent them from happening in the future
  • Ensure that corrective action is effective and does not have any adverse effects on the function of your device
  • Can implement and document corrective changes to procedure
  • Clearly communicate procedural changes 
  • Are prepared for management-level reviews of identified problems and solutions

The best way to prepare for this type of work is to build CAPA protocols into your QMS (or electronic QMS). Kapstone can help you identify and implement the right QMS for your business. Learn more about our approach here. 


Medical device companies also need to establish a system for receiving and responding to user complaints. The FDA and other regulatory bodies take this requirement seriously. In 2016, weak complaint reporting systems were the second-most common compliance issue among reviewed medical device companies.

Your system should help you track, document, and respond to complaints in a timely but thoughtful manner. Consider all the areas where complaints can be lodged and ensure that your system is set up to respond appropriately. An electronic QMS (eQMS) may be helpful—the team at Kapstone can advise in this area and help you install an eQMS if you choose to go that route.

Insufficient Medical Device Reporting

Medical device compliance is all about clear communication. Your system needs to clearly document and communicate nonconformities to your internal team and to regulatory bodies. The FDA requirements for reportable events are laid out here. You can reach out to your Kapstone team for help deciphering and implementing these key compliance regulations.

Non-Conforming Products

Even the best facilities sometimes produce faulty or otherwise nonconforming products. However, it is extremely important for medical device companies to actively review their production and testing systems in order to pull these products from distribution. 

Regulatory bodies will never fault you for a few non-compliant products—unless a few become many. But they will take corrective action if non-compliant products reach the market. 

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