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Set the Standard – ISO 13485 – Medical devices

Denis Gouletby
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ISO 13485 - Medical Devices - is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
The medical devices industry is one of the most highly regulated sectors in the world. Significant Quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose.

Medical devices range from simple bandages and tongue depressors to the most sophisticated radiotherapy equipment, implants and software for disease screening. These medical devices play an important role in the welfare of the public, whose safety depends on the quality and consistency of those medical products.

ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.However, implementing a Quality Management System that maintains the effectiveness of its processes and meeting applicable regulatory requirements can be challenging for the sector. Organizations may be treading on the finest of lines between distributing safe and effective medical devices quickly to the market, gaining the trust of customers and meeting regulatory requirements.

Organizations active in the medical device sector, such as manufacturers, importers, distributors, service providers, certification bodies or regulatory bodies, can benefit from this standard.

> Read more New handbook helps medical devices sector improve its Quality Management System | ISO.org
ISO 13485:2016 Medical devices – Quality Management Systems – Requirements for regulatory purposes

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 and design and development 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.

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What is a medical device?

A medical device is an instrument, apparatus, implement, machine, implant, in vitro reagent, or other similar article, that is intended for use in the diagnosis, prevention and treatment of disease or other medical conditions.

There is a huge variety of medical devices, ranging from basic hand tools to complex computer controlled machines. These include:

  • Simple devices like wound dressings and scalpels;
  • Durable devices like wheelchairs and dentist chairs;
  • Implantable devices like cardiac pacemakers and monitors, prosthetic limbs and prosthetic joints;
  • Life-supporting devices like respirators and lung ventilators;
  • Sophisticated, software-controlled devices like CT scanners and MRI machines;
  • In vitro diagnostic reagents and
  • Test kits

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FDA plans to use ISO 13485 for medical devices regulation

The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.

ISO handbook helps medical devices sector improve its quality management system

The medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems must be satisfied to ensure the medical devices produced are fit for their intended purpose.

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Published by Denis Goulet

Denis Goulet is a recognised expert in the Business Continuity Management System (BCMS) field with over 32 years of experience covering Financial, Telecommunication, Pharmaceutical, Industrial, Manufacturing, Distribution and Government organisations. Over the years, Denis has helped these organisations with the definition, the development, the implementation, the maintenance and the exercise of their BCMS. Since 1999, Denis has developed an international career where he provides BCMS consulting and coaching services as well as high quality BCMS training to BCMS professionals of private and public organisations, in North America, Europe, Africa and the Middle-East.

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