ISO 13485

ISO 13485 is the standard for medical device quality management system (MDQMS) that is intended to support the design, development and support of medical devices which meet applicable regulatory requirements and do no harm to patients.  An MDQMS provides the basis for maintaining the consistent quality of medical devices throughout their lifecycle from conception through design and manufacture through to disposal.

ISO 13485 is aimed at those organisations responsible for the design and / or manufacturer of medical devices through the life of that device, from initial conception to decommissioning and disposal.  This may include conceptual design, manufacture, service, support and maintenance organisations.

Implementation of an ISO 13485 MDQMS will help to ensure that the manufacturer maintains compliance with medical device regulatory requirements and the requirements of the quality management system.

ISO 13485 is aligned to several harmonised standards, including:

• BS EN ISO 14971 – Medical devices – Application of risk management to medical devices
• BS EN ISO 62304:2006 – Medical device software -  Software lifecycle processes
• EN ISO 60601 series of standards – Medical electrical equipment safety

The MDQMS is an effective management tool to support regulatory compliance across multiple markets.

URM and its consultants provide a wide range of support services covering many aspects of the MDQMS and associated regulatory compliance, to meet your specific needs.  

ISO 13485 Gap Analysis

Here, URM’s consultants carry out a gap analysis to determine where differences exist between your organisation’s current business systems, design and development processes and the requirements of ISO 13485 and/or any other identified criteria.

This analysis may be conducted as an initial step in the development of a MDQMS, when major changes occur within your organisation, or when a new version of the Standard, associated regulations or harmonised standards are released.

Develop and Establish an ISO 13485 MDQMS

URM’s consultants are able to support your organisation to:

• Determine what a MDQMS means to your organisation.
• Develop a plan to establish and implement a MDQMS
• Define the scope and structure of the MDQMS.
• As required, develop and document relevant processes
• Achieve ISO 13485 certification.

Manage and Improve an ISO 13485 MDQMS

URM’s consultants can assist your organisation to:

• Conduct internal audits
• Support management reviews
• Develop and deliver quality and internal auditor training
• Implement change
• Support alignment with and implementation of various harmonised standards associated with ISO 13485
• Integrate and align with management systems associated with other ISO standards, such as ISO 27001 and 9001.

Support alignment with relevant regulatory requirements

URM’s consultants can assist your organisation:

• Review your compliance with regulatory
• Integrate regulatory requirements into your MDQMS
• Support UK and European regulatory certification.

URM’s consultants are also able to support the review of product lifecycle documents to ensure that they meet the evidential requirements of the relevant regulations and standards.

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