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ISO 13485 - Quality Management Systems in the Medical Device Industry

If you are either a legal manufacturer, authorized representative, importer or distributor of medical devices, then this is the right standard that can be implemented in your organization.

Ensuring Quality and Safety
in the Medical Device Industry - ISO 13485

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry. Its main purpose is to ensure that organizations consistently meet regulatory requirements and customer expectations for medical devices and related services. Make sure within your quality management system, that your medical devices (incl. software as a medical device (SaMD)) achieve their intended purpose, are safe and are in compliance with applicable regulatory requirements.

Key benefits of
ISO 13485

Enhanced Product Quality

Ensures consistent production of safe, reliable medical devices that meet regulatory and customer expectations.

Regulatory Compliance

Aligns quality systems with global standards, simplifying approvals and reducing risks of regulatory noncompliance.

Effective Risk Management

Identifies, controls, and mitigates product and process risks to enhance patient safety and reliability.

Operational Efficiency

Streamlines processes, reduces waste, and improves productivity through standardized quality management practices.

Customer Trust and Market Access

Demonstrates quality commitment, strengthening brand reputation and facilitating access to international medical device markets.

  • How to establish the quality management system
    according to ISO 13485?

    Establishing ISO 13485 (a quality management system for medical devices) involves a structured approach. Here are the main steps:

    1. Understand ISO 13485 Requirements
      Study the standard to understand its clauses, especially those related to regulatory compliance, risk management, documentation, and product realization

    2. Establish Documentation
      Develop or revise required documentation, including a quality manual, procedures, work instructions, and records

    3. Train Employees
      Train relevant staff on ISO 13485 requirements, procedures, and their roles in the QMS

    4. Implement the QMS
      Put the documented procedures into practice and begin operating under the ISO 13485 system

    5. Conduct Internal Audits
      Perform internal audits to verify conformity to the standard and identify areas for improvement

    6. Management Review
      Hold formal management review meetings to assess the effectiveness of the QMS and decide on necessary actions

    7. Corrective Actions
      Address nonconformities found during internal audits through corrective actions

    8. Certification Audit
      Engage a third-party certification body to perform an audit to obtain ISO 13485 certification

Tadej Borštnar

Already established and certified management systems are my guarantee for your success

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