ISO 13485 provides an international Standard for enabling manufacturers of medical devices to substantiate an effective quality management system. This Standard refers to all organizations that are operating within the supply chain or are involved in putting devices regulated by the relevant EU directives and regulations (medical devices, in-vitro diagnostics, medical devices that can be implanted actively) into circulation.
This Standard ISO 13485 is harmonized with the applicable directives and regulations in Europe. Therefore, certification acc. to this Standard is obligatory for manufacturers of medical devices in Europe and is also increasingly being required from their suppliers.
The Standard establishes requirements for all types of medical devices, which also include services and software. The devices range from sterile to non-sterile medical devices, invasive to non-invasive medical devices as well as non-active medical devices to active implants.
In the course of the conformity review procedures required in Europe, the safety, security and functionality of medical devices need to be demonstrated in order for these products to be registered. As for conformity reviews in Europe acc. to Annex II (complete quality management system) and Annex V (quality assurance in production), demonstration of a quality management system is an important prerequisite for obtaining registration and thus the right to sell medical devices in Europe or to put them into circulation (CE marking).
ISO 13485 has some features that are congruent with those of other management systems, especially ISO 9001. A stronger focus is placed on complying with laws relevant to quality as well as risk management acc. to ISO 14971.
The advantages for organizations do not only include the registration aspects but also transparency of the organizations’ own performance, operations following defined processes and the fact that the organization is made aware of legal changes.
Furthermore, effective actions for risk management can help to minimize and thus control risks in connection with the devices concerned.
- assuring quality, transparency and safety and security
- identifying business and product risks
- important prerequisite for the registration of medical devices
Any organizations developing and manufacturing medical devices and putting them into circulation.
Application of ISO 13485 is particularly conceived for organizations striving for a management system that is wellaimed, more conclusive and more integrated. In this respect, the organization needs to meet all the applicable and legal requirements in connection with product safety in the organization’s management systems for medical devices. In addition to the criteria for ISO 9001, requirements relating to risk management will have to be met. Moreover, special requirements placed on sterile medical products and medical products that can be implanted actively will have to be met. Internal and external audits are to provide relevant support.
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