ISO 13485.

Guarantee the quality of medical devices

La ISO 13485. is a specific quality management system standard for companies of the medical sector, which includes aspects of the standard ISO 9001. and specific requirements for the of medical devices.

The European Directive 93/42 / EEC regulates medical devices which include a very wide range of substances and products: a medical device is in fact any instrument, device, implant, substance or other product, used alone or in combination, including software computer used for correct functioning, intended by the manufacturer to be used in humans for the purpose of:

  • diagnosis, prevention, control, therapy or mitigation of one disease;
  • diagnosis, control, therapy, alleviation or compensation of a wound or a handicap;
  • study, replacement or modification ofanatomy or of an physiological process;
  • of intervention on conception, which product does not exert the main action, in or on the human body, for which it is intended, by pharmacological or immunological means or by metabolic process but whose function can be assisted by such means.

La Certification ISO 13485: 2016 Medical devices-Quality Management Systems - Requirements for regulatory purposes, is a standard harmonized with the European Directives on Medical Devices. The standard specifies i requirements for a quality management system in cases where an organization has to prove its ability to supply medical devices and related services that meet customer requirements and meet regulatory needs regarding medical devices and related services. The standard was created with the intention of merging the previous ISO 13485 and ISO 13488 together by integrating and updating their contents.

Advantages for the company that certifies itself

Certification Process

> Request for an offer from the customer interested in certification

> Acquisition of all the information necessary for the certification and issue of the offer by AX-REGISTER

> Acceptance of the offer by the customer


> Analysis of any gaps and assessment of the current compliance of the ISMS with the regulatory requirements

> Verification aimed at evaluating the implementation of the principles and structure of the Management System (applicable legislation and regulations, security policy, risk analysis, Statement of Applicability (SoA), clear and consistent definition of the purpose, risk treatment plan)

> Verification aimed at evaluating the adequate and effective implementation of the Management System, through techniques that involve the analysis of documents, observations, interviews with personnel.

> This verification is aimed at issuing the certificate

> Audit carried out annually after certification, to check continuous improvement

> The Renewal Audit is carried out after three years following a complete verification or continuous evaluation over time.

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