Glossary Term
Gap Analysis
Definition
Gap Analysis is a systematic process used to compare a company’s current performance, capabilities, or compliance status against desired goals, industry standards, or regulatory requirements. It identifies gaps and provides actionable insights to bridge them, ensuring alignment with objectives and compliance.
Relevance to the MedTech Industry
In the MedTech industry, gap analysis is essential for ensuring that processes, products, or systems meet regulatory requirements, quality standards, and market demands. It is frequently applied during audits, product development, and market readiness assessments to identify deficiencies and implement improvements.
Additional Information & Related Terms
Examples of Applications
Regulatory Readiness: Assessing a device’s compliance with EU MDR to ensure readiness for CE marking.
Quality Systems: Identifying gaps in a company’s Quality Management System (QMS) relative to ISO 13485 standards.
Market Entry: Evaluating gaps in product performance data to meet the requirements of new international markets.
Post-Market Surveillance (PMS): Analyzing the completeness of adverse event reporting systems to align with FDA or EMA requirements.
Steps in a Typical Gap Analysis
Define Goals: Establish target benchmarks or requirements.
Assess Current State: Review existing processes, systems, or performance.
Identify Gaps: Highlight deficiencies relative to the target benchmarks.
Develop an Action Plan: Create strategies to address gaps and assign responsibilities.
Implement and Monitor: Execute the plan and monitor progress toward closing gaps.