ISO 13485 consultancy

  • ISO 13485 certification
  • Easy to use ProActive ISO 13485 QMS
  • Increased market access
  • Increased efficiencies
  • ISO 13485 certification
  • Easy to use ProActive ISO 13485 QMS
  • Increased market access
  • Increased efficiencies

ISO 13485 Medical Devices 

ISO 13485:2016 is the international quality management standard for the design and manufacture of medical devices. The current ISO 13485 standard is largely based on ISO 9001. 

Certification to ISO 13485 is particularly beneficial for organisations who manufacture medical devices. ISO 13485 is also relevant to companies in the supply chain and offering service support to manufacturers.

If your company exports medical devices and want to gain access to new markets, the standard provides a globally recognised quality system that may meet the market's requirements and save you valuable time and cost.

ISO 13485:2016 will provide you with a QMS that will:

ü  Demonstrate your commitment to product quality

ü  Improve quality control

ü  Manage risks

ü  Comply with any legal and regulatory requirements

ü  Provide improved operational efficiency

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Your organisation will soon benefit from an effective quality system for medical devices that is both easy to use and highly effective. ISO 13485 consultancy covers the creation of procedures for internal audits, document control, records control, control of non-conforming products/services and corrective and preventive action. Records including calibration, training are each fully referenced or accessible from a ProActive web page or hyper-linked from an electronic quality manual within your Cert’N made easy package.

DAT Performance also provide ISO 13485 gap analysis services, internal audits and bespoke  consultancy services for clients wishing to improve, replace or integrate their existing ISO 9001 system with other standards such as ISO 14001, OHSAS 18001 or ISO 27001.

ISO 13485 management systems are prepared to the highest possible standard using down to earth and highly experienced consultants. They produce excellent results using a simple, jargon free methodology.


  • ISO 13485 certification (UKAS or other nationally accredited body)
  • Easy to use Quality Management System
  • Regulatory compliance
  • Reduced costs of failure, waste complaints etc.
  • Improved quality and service performance
  • Tender pre-qualification barriers removed
  • Enhanced reputation with existing and potential customers
  • Improved product and service reliability
  • Value added performance improvement


ISO 13485 forerunner standards were EN46001 eventually becoming ISO 13485: 1996 based on the quality management standard ISO 9001: 1994. The current ISO 13485: 2003 is a single standard again largely based on ISO 9001.

ISO 13485 was revised in 2016 mainly because the medical device regulatory environment had evolved considerably since 2003.

Additionally risk management and risk-based processes have become focal for the entire medical device industry both at a quality system level and product level. 

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