ISO 13485

Medical Devices

What is ISO 13485?

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

Benefits of an ISO 13485 Certification

  • Access to wider markets
  • Improved customer confidence
  • You do not need to produce regulated medical devices to gain certification to this standard
  • Regulatory compliance
  • Improved risk management
  • Better supplier management

Certification Process - We have a 100% success rate!

With MQF the certification process is not just about ticking the right boxes to get the certificate. The most important outcome is that you benefit as a business.

MQF advise clients throughout the whole process. We have environmental experts with Masters Degrees in Environmental Management and Environmental Law who have vast experience in ISO 13485 systems.

The time it takes to get certification will depend on the size and complexity of your organisation, but we will set a timetable from the outset.  Having installed numerous ISO systems across a wide range of business sectors since 1991, we know how to manage the process to get you to certification within the right timescales for you.

We will design, document, and implement an Environmental Management System that meets all the requirements of ISO 13485, but more importantly enhances your business and works for you to improve your environmental performance and, in many cases, save you money.

As an integral part of our service we will help you choose the right UKAS accredited Certification Body for your business, and will guide you through the whole certification process. Our work is not complete until you gain certification.


Ongoing Support

As experienced ISO 13485 consultants, MQF provide continuing consultancy support and an internal audit service for many of our clients to maintain and improve existing systems.

Our Fees

We price each job individually taking into account the size of the organisation and the complexity of the work undertaken. We operate a fixed fee policy so that you know exactly what you are paying, with no hidden costs.

Radcliffe Camera - ISO Consultants Oxfordshire