GAP analysis

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What is a GAP Analysis?

A GAP analysis is a systematic method used to assess the current state of an organization's processes and documentation against the desired state defined by a standard or regulation. This comparison highlights the "gaps" that must be addressed to meet compliance requirements. The outcome is a detailed action plan that prioritizes what needs to be updated, developed, or improved.

Why Conduct a GAP Analysis for ISO 13485 and FDA Compliance?

Not only ISO 13485 and FDA regulations demand comprehensive documentation, risk management, validation procedures, design controls, and traceability mechanisms but these analysis are a useful tool to evaluate the deficiencies in a company in regard of regulatory compliance or expectations overall. Conducting a GAP analysis helps to the following parts:

  • Identify Deficiencies Early: Proactively pinpoint areas where current practices fall short.

  • Support Strategic Planning: Enable resource allocation based on risk and regulatory impact.

  • Facilitate Efficient Implementation: Reduce time and cost during the transition by focusing only on necessary changes.

  • Enhance Readiness for Certification or Inspection: Provide confidence during third-party audits or FDA inspections.

Typical GAP Analysis Steps

There are different approaches to identify the differences between the current state and the archivable state. A gap analysis can be broken down to the following steps:

  1. Define Scope and Objectives – Clarify if the analysis targets ISO 13485 certification, FDA QSR compliance, or both.

  2. Collect Existing Documentation and Process Descriptions – Review SOPs, records, organizational charts, training files, etc.

  3. Compare with Standard Requirements – Perform clause-by-clause (or section-by-section) assessments.

  4. Document Identified Gaps – Note where procedures, records, or practices are absent, incomplete, or non-compliant.

  5. Prioritize Gaps by Risk and Impact – Use tools such as risk matrices or failure mode analysis to rank findings.

  6. Develop and Implement Action Plans – Assign responsibilities, timelines, and milestones.

  7. Monitor Progress and Validate Outcomes – Regularly review implementation progress and verify changes.

Some hypothetical examples are given below to further increase the understanding, why a systematic approach in this step is crucial.

  1. Example: GAP Analysis for ISO 13485:2016 Compliance

Scenario: A medium-sized company manufacturing diagnostic kits for export is seeking ISO 13485 certification. The company has an informal quality system based on ISO 9001:2015.

Key Finding Example:

  1. Clause 7.3 – Design and Development
    Current State: The company conducts R&D but lacks formal design and development procedures, including no documentation for design inputs, design reviews, or verification/validation activities.
    Gap: ISO 13485 requires documented procedures for design and development with traceable records of each stage.
    Action: Develop a comprehensive Design and Development SOP, implement templates for recording design inputs and outputs, and define stages for reviews and approvals.

  2. Clause 4.2.4 – Control of Documents
    Current State: Quality documents are managed via local file storage with no version control or formal approval records.
    Gap: ISO 13485 mandates document control with version history, approval signatures, and access control.
    Action: Implement a document control system (manual or electronic), define a Document Control SOP, and train staff on proper document handling.

2. Example: GAP Analysis for FDA QSR (21 CFR Part 820)

Scenario: The same company now plans to enter the U.S. market.

Key Finding Example:

  • 820.75 – Process Validation
    Current State: The company performs final testing but does not validate sterilization processes or critical manufacturing steps.
    Gap: FDA requires documented validation of all processes where output cannot be fully verified by inspection or testing.
    Action: Conduct process validation studies (e.g., for sealing, sterilization), document protocols and results, and establish revalidation criteria.

The Strategic Role of GAP Analysis in ISO 13485 and FDA Compliance Implementation

Implementing a compliant Quality Management System (QMS) for medical devices is a complex endeavor. Whether the organization is preparing for ISO 13485:2016 certification or aligning with U.S. FDA Quality System Regulation (21 CFR Part 820), conducting a comprehensive GAP analysis is a crucial first step toward achieving full regulatory compliance.

A diagram illustrating a process from current state to compliance, including steps for GAP analysis and action plan.
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Make it

Close the GAP to Compliance

Conducting a GAP analysis is not just a best practice—it’s an essential step in achieving and maintaining compliance with global regulations. By systematically comparing current practices against recognized standards, organizations gain a clear picture of their compliance status and the roadmap needed to reach full conformity.

A well-executed GAP analysis allows companies to prioritize corrective actions, allocate resources efficiently, and prepare for certification or regulatory inspections with confidence. For medical device and biotech firms operating in global markets, it is a critical building block of a robust regulatory strategy.

At SciReg Consulting, we actively support every phase of your GAP analysis—from initial assessment to actionable remediation plans—ensuring that your systems are aligned, inspection-ready, and globally defensible.

Partner with SciReg Consult to transform your GAP analysis into a compliance roadmap that accelerates readiness and builds long-term regulatory confidence.
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  • A GAP analysis is a structured comparison between your current manufacturing practices and the applicable GMP requirements for ATMPs. It highlights missing elements, weak points, or non-compliant processes so they can be corrected before an inspection or product release. For newcomers, it’s the most effective way to understand where you stand and what needs improvement.

  • In the EU, GAP analyses for ATMPs are typically based on EU GMP Part IV and relevant Annexes (such as Annex 1 for sterile production). EMA guidelines, national authority requirements, and — if applicable — FDA or other regional GMP standards are also included to ensure compliance across markets.

  • It all begins with an idea. Maybe you want to launch a business. Maybe you want to turn a hobby into something more. Or maybe you have a creative project to share with the world.