ISO 13485​ ​Medical devices

The specific quality standard for manufacturers of medical devices is UNE-EN ISO 13485. It is recognised throughout the world and is essential for the international commercialisation of a product. All manufacturers of medical devices have a responsibility to supply safe and efficient equipment.

What is a medical device?

According to ISO 13485: 2016, a medical device is understood to be an instrument, tool, equipment, computer program, implant, reagent, material or other article intended by the manufacturer to be used in people, separately or in combination, with any of the following specific medical purposes:

une en iso 13485 para fabricantes de productos sanitarios

  • Diagnosis, prevention, monitoring, prognosis, treatment or alleviation of diseases;
  • Diagnosis, prevention, monitoring, prediction, cure or mitigation of injuries or disabilities;
  • The investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
  • Support or sustaining of life;
  • Control or support for conception;
  • Products specifically intended for cleaning, disinfection or sterilisation of medical devices and their accessories;
  • Obtaining information by in vitro examination of samples from the human body (including organs, blood and tissue donations),

that do not exert their intended main action inside or on the surface of the human body by pharmacological, immunological or metabolic mechanisms, but to whose function such mechanisms may contribute.

As examples of sanitary products, we put the following:

  • Products to collect body fluids (urine bags), products to immobilize parts of the body or to apply compression (bandages, elastic stockings), products for patient support (walkers, canes), others (glasses, enemas, recognition lamps)…
  • Exam gloves, syringes, gravity infusion sets, gauze to protect wounds or to absorb exudates, reusable surgical instruments…
  • Examples: cardiopulmonary bypass circuits, urological probes, surgical drains, needles, cannulas, surgical gloves, contact lenses, hearing aids, muscle stimulators: TENS, sphygmomanometers, diagnostic equipment, physiotherapy equipment.
  • Examples: intraocular lenses, tissue filler implants, nonabsorbable surgical sutures, wound dressings that heal by secondary intention, blood bags, hemodialyzers, insulin pens, external defibrillators, diagnostic X-ray machines, surgical lasers, equipment for radiation therapy, intensive care monitoring systems, anaesthesia machines, condoms.
  • Examples: heart valves, hip replacement, breast replacement, stents: stents, cardiovascular catheters, absorbable sutures, biological internal tissue adhesives, antibiotic endodontic materials, antimicrobial agent dressings, heparin-coated catheters, spermicidal condoms , bovine vascular patches, collagen dressings.
  • Example: dental prostheses, orthopaedic corsets…
The UNE-EN ISO 13485 standard

UNE-EN ISO 13485 determines the requirements of a quality management system for organisations involved in one or more stages of the life cycle of a medical device. Therefore, it can cover the design and development, production, storage and distribution, installation, technical assistance and the final uninstallation and disposal of medical devices as well as the design and development or provision of related services (example, technical support).

ISO 13485 is also applied by suppliers, subcontractors or other external parties supplying products (e.g. raw materials, components, sub-assemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to organisations and healthcare facilities.

ISO 13485: 2016 was based on UNE-EN ISO 9001: 2008 and does not have the structure of other more modern standards (in its annexe B it shows the correspondence between this international standard and ISO 9001: 2015).

We provide solutions

Our consulting services are intended to help the company to the interpretation of the standard, and design and prepare the entire documentary base that is going to be required.

After the implementation and improvement process, we provide support to the organisation in the certification inspection (Aenor, BSI, Lloyd’s Register, DNV GL Business Assurance, Bureau Veritas…).

Our company has been providing advisory and consulting services in the field of standardisation for more than 20 years. We will be here today and tomorrow to help you. Our commitment to customers opens doors for us and makes us a benchmark in the sector.


This solution is aimed at
  • Manufacturers of any medical device (regardless of its classification according to Regulation (EU) 2017/745).
  • Health-related service providers.
  • Manufacturers of raw materials and accessories for sanitary products.
What our customers get

Company registration certification UNE-EN ISO 13485. Bodies that certify this standard: Aenor, BSI, Lloyd´s Register, DNV GL Business Assurance, Bureau Veritas…

Satisfied customers

ISO 13485 management systems can be easily combined with any ISO 9001, ISO 14001 or ISO 45001 management system and are closely related to CE Marking medical devices.
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