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)
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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