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QMS Development

Building a compliant, effective, and scalable Quality Management System doesn’t have to be overwhelming. At HeurNova Consulting, we specialize in developing QMS frameworks aligned with ISO 13485, 21 CFR 820, and global regulatory expectations — whether you’re a startup establishing your first system or a mature organization seeking modernization.

 

Our QMS Development services begin with understanding your operational structure and product portfolio, allowing us to design processes that are lean, traceable, and right-sized to your organization. From establishing document control, training, and supplier management systems to integrating design controls, risk management, and post-market surveillance, we ensure every element works cohesively to support compliance and continuous improvement.

 

We don’t just build systems — we engineer them to evolve with your business. Through tailored implementation plans, internal audit readiness, and change management support, we help you lay a foundation that adapts seamlessly as your product lines, regions, and regulatory demands expand.

 

No matter your starting point, our goal is the same: to help you develop a QMS that not only meets regulatory requirements but empowers your team to deliver safe, reliable, and high-quality medical devices with confidence.

QMS Planning & Framework Development

Would you like to establish a compliant, scalable Quality Management System from the start? Our QMS Planning & Framework Development service ensures your organization is aligned with ISO 13485 and relevant regulatory expectations while remaining practical for your operations.

 

We help define your quality objectives, organizational roles, process structure, and documentation hierarchy to build a system that supports growth rather than restricts it. With a framework that is intentionally structured and easy for your team to follow, you create a strong foundation for consistent quality, regulatory clarity, and long-term scalability.

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

  • Scope of the QMS (product types, markets, and regulatory frameworks)

  • Organizational chart and key quality roles/responsibilities

  • Quality policy and measurable quality objectives

  • Process interaction map (linking design → production → post-market)

  • Integration with existing business or project systems

  • Records retention and documentation hierarchy

  • Internal communication and escalation routes

Quality Manual & Documentation System

Is your documentation structured in a way that is both compliant and easy to maintain? We develop and refine Quality Manuals and controlled document systems that clearly define your QMS structure, simplify day-to-day use, and support efficient audits.

 

Our documentation approach focuses on usability, ensuring that procedures are readable, logical, and aligned with real operational practices — not written for auditors only. This enables your team to follow and reference documentation confidently and consistently.

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

  • ISO 13485 clause alignment for all required elements

  • Controlled document structure (manual → SOPs → work instructions → forms)

  • Document control procedure (approval, revision, distribution, archival)

  • Electronic vs. paper-based systems (Part 11 compliance if electronic)

  • Controlled templates for records, logs, and evidence of activities

  • Training logs on document awareness and use

Process Development & Mapping

Are your core business processes clearly defined and understood across your organization? Our Process Development & Mapping service clarifies how your workflows operate, where decisions are made, and how responsibilities flow across teams.

 

We can create visual and narrative process maps that highlight key risks, dependencies, and compliance control points. By establishing clarity and operational alignment, your organization gains efficiency and reduces the likelihood of failure, rework, or quality lapses.

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

  • Mapping each QMS process with defined inputs, outputs, and interactions

  • Ownership of each process (assigned process owners)

  • Performance indicators (KPIs) and metrics for each process

  • Standardized process flowcharts for audit clarity

  • Linkages to risk, CAPA, and management review

  • Validation or qualification required for key processes

Gap Assessment & Remediation

Are you confident your QMS fully meets ISO 13485 and regulatory expectations? We conduct targeted gap assessments to evaluate your existing processes, documentation, and controls against applicable standards and regulations.

 

Our findings are translated into clear, prioritized remediation actions with practical guidance, templates, and support to help your team close gaps efficiently. This ensures your QMS is not only compliant on paper but functional and defensible in practice.

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

  • Comparison matrix (current vs. ISO 13485, MDR, or FDA requirements)

  • Evidence of compliance or noncompliance (documented examples)

  • Prioritization of gaps by risk or audit impact

  • Corrective action plan with deadlines and ownership

  • Verification of remediation effectiveness

  • Traceability matrix for closure of all findings

Design & Development Controls

Do your design and development activities follow a controlled, traceable, and compliant process? We help establish and refine design control frameworks including user needs, design inputs/outputs, verification, validation, risk management, and design transfer.

 

Our support ensures each stage is documented clearly and consistently, enabling robust traceability and reducing regulatory and safety risks. This structured approach streamlines development while ensuring products meet intended clinical and performance requirements.

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

  • Documented design and development plan

  • Defined design stages and reviews

  • Design input/output traceability

  • Verification vs. validation evidence (with protocols and reports)

  • Risk management integration at each phase

  • Supplier or lab reports for outsourced testing

  • Design transfer checklist to production

Risk Management Integration

Would you like to ensure risk management is embedded throughout your product lifecycle? We assist in aligning ISO 14971 risk management practices with design, production, post-market feedback, and change control processes.

 

Our approach creates a living risk framework that supports decision-making and continuous improvement — not a one-time deliverable. This integration improves product safety, audit readiness, and clinical trust

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

  • Alignment with ISO 14971 lifecycle approach

  • Comprehensive hazard identification and mitigation

  • FMEA or Fault Tree Analysis templates

  • Risk acceptability criteria (aligned with company policy)

  • Link between risk file, Complaints, NCR, and CAPA processes

  • Review and update frequency of risk management files

  • Documentation of residual risks and communication to users

Supplier & Purchasing Controls

Are your suppliers demonstrating the same level of quality you commit to your customers? We help you establish and manage supplier qualification, approval, monitoring, and control systems that align with ISO 13485 and regulatory expectations.

 

This ensures that purchased components and services consistently meet your quality and performance needs. With effective supplier oversight, you reduce operational risk and maintain strong compliance control across your supply chain.

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

  • Supplier qualification and approval criteria

  • Supplier audits or questionnaires (based on risk classification)

  • Quality agreements outlining responsibilities and traceability

  • Incoming inspection and acceptance criteria

  • Supplier performance monitoring (KPIs, scorecards)

  • Control of outsourced processes and subcontractors

  • Handling of supplier nonconformances

​Training & Competence Management

Is your team trained effectively and able to demonstrate competence? Our Training & Competence Management service helps you define role-based training needs, develop training materials, and maintain qualification and competency records.

 

We create training systems that are easy to maintain and meaningful for your team, ensuring they understand why controls exist — not just how to follow them. Strong training systems support audit readiness and consistent execution.

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

  • Training needs analysis for each role

  • Competency matrix and job descriptions

  • Initial training, retraining, and periodic evaluations

  • Training effectiveness verification (quizzes, observation, or audits)

  • Recordkeeping of completed training and sign-offs

  • Control of trainers and training materials

CAPA & Nonconformance Management

Are issues in your organization being resolved effectively and prevented from recurring? We help structure your CAPA and nonconformance systems to support root cause analysis, corrective action planning, and effectiveness verification while maintaining efficiency and clarity.

 

Our focus is on developing systems your team can actually use day-to-day—not overly burdensome processes that stall progress. This leads to continuous improvement and stronger quality culture.

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

  • Defined CAPA workflow (initiation → investigation → closure)

  • Root cause analysis tools (5 Whys, Fishbone, etc.)

  • Severity, frequency, and detectability criteria for prioritization

  • Evidence of correction vs. corrective action

  • Verification of CAPA effectiveness and long-term monitoring

  • Trending analysis to identify systemic issues

  • Linkages with risk and management review

Internal Audit & Management Review

Would you like your audits and management reviews to drive improvement — not just fulfill requirements? We develop audit programs and management review processes that identify meaningful opportunities, support decision-making, and demonstrate leadership oversight.

 

Whether you need full audit execution support or a framework your team can maintain independently, we help ensure your QMS remains active, monitored, and effective.

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

  • Audit program covering all ISO 13485 clauses over a cycle

  • Auditor qualification and independence

  • Audit checklist and sampling approach

  • Handling and tracking of audit findings

  • Management review agenda (inputs: KPIs, audit results, complaints, CAPA, etc.)

  • Meeting minutes and action item tracking

  • Continuous improvement documentation

Production, Storage & Distribution Controls

Are your production and distribution processes adequately controlled to ensure consistent product quality? We help define and document control plans, work instructions, environmental conditions, equipment qualification, warehouse controls, and distribution traceability. Our goal is to ensure your operations consistently produce safe, compliant devices — even as demand scales or processes evolve.

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

  • Controlled production environment and equipment qualification

  • Work instructions, process validation, and batch records

  • Calibration and preventive maintenance schedules

  • Environmental control (temperature, humidity, cleanliness)

  • Material identification, segregation, and traceability

  • Storage and handling of finished goods and returned products

  • Distribution record retention and control of transport conditions

Post-Market & Feedback Integration

Do you have a structured approach to collecting, analyzing, and responding to post-market feedback? We support the development of surveillance plans, complaint handling systems, vigilance reporting pathways, and trend analysis practices that align with both regulatory and clinical expectations.

 

This ensures your organization maintains continual oversight of product performance and patient safety — supporting compliance, trust, and lifecycle quality.

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

  • Complaint handling and investigation procedure

  • PMS plan and data sources (user feedback, trend analysis, vigilance)

  • Integration with CAPA and risk management

  • Reporting obligations under MDR (serious incidents, etc.)

  • Periodic Safety Update Reports (PSUR) for higher-risk devices

  • PMCF plan and execution (where applicable)

  • Communication of lessons learned to R&D and manufacturing

Multi-Standard Integration

Do you operate in regions or markets that require alignment to more than one standard? We help integrate ISO 13485, FDA QSR/QMSR, EU MDR expectations, and other regulatory frameworks into a unified system that is efficient rather than duplicative.

 

This reduces administrative burden, streamlines audits, and supports global scalability while maintaining clarity and compliance.

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

  • Mapping between ISO 13485, ISO 9001, and 21 CFR Part 820 clauses

  • Unified procedures for overlapping requirements (e.g., CAPA, audits)

  • Cross-functional training to handle multiple regulations

  • Consistency between global and local procedures

  • Centralized document control for multiple certifications

  • Harmonized quality objectives and management reviews

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