Demonstrate your commitment towards the Quality of Medical Devices. Prove that your medical device is safe and that it complies with all the relevant legislative requirements.
What is ISO 13485?
This standard specifies the Quality Management System requirements for companies active in the design, production, sale, installation and servicing of medical devices. This standard:
- Puts special emphasis on risk management and decision making based on the risks involved in the processes that do not concern implementation of the product. Focuses on the risks related to the safety and performance of medical devices and their compliance with regulatory requirements.
- Requires organizations to carry out stricter controls in case of outsourcing of processes, implementing written agreements for assessment of their suppliers based on risk. Responds to the increased regulatory requirements for organizations throughout the medical-device supply chain.
It should be noted that this standard does not follow the Annex SL structure employed in the new versions of latest ISO 9001 and ISO 14001.
Who is it for?
This certification is designed for all businesses operating in the medical device industry.
The benefits of ISO 13485
The advantages of application and certification of an ELOT EN ISO 13485 Quality Management System are summarized as follows:
- ensures the business’s compliance with the requirements of the applicable national and European Legislation on medical device products
- Strengthens user/consumer confidence and assurance that the medical device complies with the requirements of the international, European and national standards, as well as with the existing European and national legislative and regulatory provisions
- timely notification of consumers, users, the National Organization for Medicines (EOF) and the competent European authorities regarding any incident involving the medical device, and confirmation of the effectiveness of corrective actions taken
- recognition of the certification by all interested parties (users, consumers, manufacturers, authorized dealers, importers, distributors, the EOF and the competent European authorities) in the international, European and national markets.