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ISO 13485 Gap Analysis
Evaluate your QMS against ISO 13485 and other country-specific requirements
A QMS gap analysis is a powerful tool to identify the distance between your current Quality Management System and a specific regulatory standard. It's not just about finding problems; it's about creating a clear roadmap to compliance and improving your overall system efficiency.
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Unlike a required internal audit, a gap analysis is a proactive, voluntary assessment. While an internal audit formally checks compliance with an existing QMS, a gap analysis helps you understand what's missing before you even have a complete system or when you're preparing for new market entry. It provides a forward-looking strategy rather than a backwards-looking verification.​​
Gap Analysis Services
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ISO 13485:2016
Assess your QMS against the international standard for medical device quality.
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EU MDR (European Medical Device Regulation)
Identify gaps to meet the strict QMS requirements for market access in Europe.
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21 CFR Part 820 ( US FDA)
Identify gaps according to the US FDA regulations.
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SAHPRA (South Africa)
Identify gaps according to the SAHPRA regulations.
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Other Juristictions
We also provide gap analysis services for a variety of other markets. Please contact us to discuss your needs for jurisdictions like Australia, New Zealand, Health Canada, Brazil, Japan, ASEAN, SADC or others.
Your Gap Analysis Deliverables
For every gap analysis, we offer
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A detailed report that highlights all identified gaps and provides clear recommendations for closing them. This gives you a strategic roadmap to achieve compliance and improve your QMS.
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We can also provide an optional, customised remediation plan for an additional cost, offering a ready-to-use action plan to guide you in resolving all identified issues.