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ISO 13495 Gap Closure & Harmonization

Whether you’re building your Quality Management System from the ground up or refining an established framework, Heurnova Consulting meets you exactly where you are. Our ISO 13485 support services cover every stage of compliance — from Gap Analysis and Baseline Mapping that reveal where improvements begin, to Corrective Action and Gap Closure Planning that transforms findings into achievable results. We guide you through Harmonization of Documentation and Processes to ensure global consistency, provide tailored Training and Change Management for seamless adoption, and perform Verification and Readiness Audits to confirm you’re fully prepared for certification or inspection.

 

No matter your organization’s starting point, we align our expertise to your needs — helping you build, strengthen, and sustain a compliant, efficient, and future-ready Quality Management System.

Gap Assessment & Baseline Mapping

Would you like to clearly understand how your current Quality Management System measures up against ISO 13485 and related global standards? Our Gap Analysis and Baseline Mapping service provides a detailed, clause-by-clause evaluation of your QMS to reveal compliance strengths, weaknesses, and improvement opportunities.

 

We create a clear traceability matrix mapping your existing documentation and processes to ISO 13485:2016 (+A11:2021), MDSAP, EU MDR, and 21 CFR 820 (QMSR) requirements. You’ll receive actionable insights into what’s fully compliant, what’s partially aligned, and what needs immediate attention — along with prioritized recommendations to help you achieve a complete, audit-ready system.

Deliverables we can provide include, but are not limited to:

  • Comprehensive Gap Assessment Report (aligned with ISO 13485:2016 and 21 CFR 820)

  • Baseline QMS Compliance Matrix

  • Document Control System Audit Summary

  • Risk & Process Mapping Analysis

  • Prioritized Action Plan for Compliance Gaps

  • Executive Summary Deck outlining key nonconformities and recommendations

Corrective Action & Gap Closure Plan

Would you like a clear, actionable roadmap to bring every part of your Quality Management System into full compliance? Our Corrective Action and Gap Closure Plan turns complex audit findings into structured, achievable steps.

 

We translate each identified gap into a defined remediation task with assigned ownership, risk-based prioritization, and measurable timelines. Whether your organization needs minor document revisions or full procedural redesigns, we ensure that every corrective action aligns with ISO 13485:2016 expectations for risk management and continual improvement.

 

Each plan includes built-in CAPA tracking for transparency and verification — helping you demonstrate closure effectiveness during internal, Notified Body, or FDA inspections with confidence and clarity.

Deliverables we can provide include, but are not limited to:

  • Corrective and Preventive Action (CAPA) Register

  • Detailed Gap Closure Implementation Plan with timelines and owners

  • Updated Procedures and Work Instructions addressing identified gaps

  • Verification-of-Effectiveness (VoE) Plan and Results Summary

  • Progress Tracking Dashboard for remediation milestones

  • Evidence Package for Auditor Submission

Harmonization of Documentation & Processes

Would you like your entire Quality Management System to speak the same language —clear, consistent, and audit-ready across every site and department? Our Harmonization of Documentation and Processes service aligns your QMS framework with current ISO 13485:2016 (+A11:2021) and regional regulations such as EU MDR, 21 CFR 820 (QMSR), and MDSAP.

 

We modernize and unify your Quality Manual, SOPs, and controlled records to ensure consistent formatting, numbering, and terminology across all procedures. Outdated or redundant documents are streamlined, while templates, forms, and records are standardized to simplify training and inspection readiness.

 

We also support seamless integration into digital systems like eQMS, SharePoint, or MasterControl, ensuring controlled versioning and traceability that strengthen long-term compliance and global alignment.

Deliverables we can provide include, but are not limited to:

  • Harmonized Quality Manual and SOP Framework

  • Process Flow Maps (pre- and post-harmonization comparison)

  • Document Control Matrix and Numbering System

  • Unified Templates for QMS Documentation (e.g., Forms, Records, Checklists)

  • Cross-functional Process Alignment Report

  • Procedure-to-Standard Mapping Table (ISO 13485 vs. 21 CFR 820 vs. EU MDR)

Training and Change Management

Would you like your teams to not only understand compliance updates but confidently apply them in daily operations? Our Training and Change Management service ensures that every process improvement and documentation update becomes part of your organization’s culture — not just a checklist item.

 

We design targeted training programs that focus on the practical application of revised procedures, integrating real-world examples from audits and production environments. Each session is tailored to specific roles — engineers, quality specialists, and leadership teams — ensuring clarity, accountability, and long-term retention.

 

To support continuous improvement, we provide structured change management plans that document communication strategies, competence records, and management review inputs, fulfilling ISO 13485 §6.2 requirements while promoting lasting alignment and staff engagement.

Deliverables we can provide include, but are not limited to:

  • Training Plan and Curriculum aligned to updated QMS procedures

  • Competence Matrix (by role/function)

  • Change Impact Assessment and Communication Plan

  • Training Attendance Logs and Assessment Records

  • Awareness Presentation Decks for internal teams

  • Controlled Record of Change Implementation Summary

Verification & Readiness Audit

Would you like to feel fully confident before your next ISO 13485 certification or regulatory inspection? Our Verification and Readiness Audit service provides an objective, end-to-end review of your Quality Management System to confirm that all corrective actions, documentation updates, and harmonized processes are fully effective.

 

We conduct mock internal audits modeled after Notified Body, FDA, and MDSAP audit frameworks — assessing real-world readiness rather than theoretical compliance. Each audit includes verification of closed gaps, sampling of records, and evaluation of process interactions to confirm sustained alignment with ISO 13485:2016 (+A11:2021) requirements.

 

Following the audit, we deliver a readiness report outlining any remaining observations, suggested preventive measures, and supporting evidence for management review. The result: a confident, inspection-ready organization built on verified compliance and continuous improvement.

Deliverables we can provide include, but are not limited to:

  • Internal Audit Schedule and Checklist aligned with ISO 13485 and regulatory expectations

  • Readiness Audit Report with objective findings and grading

  • Corrective Action Tracker for pre-certification audits

  • Evidence Binder or Audit Package (documentation samples and traceability)

  • Management Review Input Summary and Output Minutes

  • Certification Readiness Statement or Executive Summary

Get a Quote

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