Conducting Gap Analysis for Medical Devices

Gap analysis might be a familiar phrase, but it has a specific meaning in the medical device industry. Effective gap analysis for medical device companies is all about regulatory compliance: in what ways are your processes and technical documentation already compliant, and where do you have to improve to achieve compliance? Kapstone can help you move through these steps efficiently.

Scope of Compliance

A gap analysis is typically compared against a common standard or regulation, depending upon the markets that product is cleared or approved for selling.

Kapstone is able to conduct gap analyses regarding the major regulations including:

  • US FDA Quality System Regulation (QSR)
  • EU Medical Device Regulation (MDR)
  • EU In Vitro Device Regulation (IVDR)
  • Health Canada Medical Devices Regulations
  • And more

A typical gap analysis will investigate:

  • Quality Management System
  • Procedures
  • Documentation or history of procedure usage
  • Technical Documentation
  • Design History File
  • Technical File
  • Design Dossier (or Technical Documentation)

Evaluating Compliance

Demonstrating Areas of Compliance

Established medical device companies may already have areas of proven compliance. It’s important to identify and document those areas before changing a process or documentation. A gap analysis should evaluate internal processes deliberately, documenting areas of existing compliance in a clear and traceable manner.

Finding Areas of Non-Compliance

After establishing areas of compliance, next should be documenting the gaps. Gaps are completely normal and not always a cause for concern. Regulatory guidance in the medical device industry is constantly changing, meaning that companies constantly have to shift their internal processes and procedures to keep up. Take the gap analysis as an opportunity to optimize before things go awry.

Closing the Gap

The gap analysis will conclude with a report that lists out action items that will take you from non-compliance to compliance. The list can include a prioritization to help identify tasks that are more critical or urgent than gaps that may not be required. Converting, or maintaining, this list as a living document can also prove to regulatory bodies that you have remedied all existing compliance gaps once fully addressed.

Kapstone can help in both performing a gap analysis appropriate for the scope of your company and remediating any identified gaps according to the report.

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