Safety and quality are uncompromising when it comes to medical devices. A small safety issue could lead to a life or death situation. This is why the International Organization for Standardization (ISO) came up with the ISO 13495 standard that guarantees the safety of medical devices. It is an extension of the popular standard, ISO 9001, and hence also deals with the maintenance of an effective Quality Management System but specifically developed for the manufacture of medical devices.
Similar to ISO 9001, ISO 13485 is essentially about helping companies produce safe and high-quality products, consistently. However, ISO 13585 is specific to medical-based industries or organizations providing medical materials, services, or devices. Hence, it is focused on helping companies meet the specific demands and stipulations that come with manufacturing medical apparatuses and other healthcare-related components. The process of ISO 13485 certification is focused on ensuring safe and effective planning, development, production, storage, distribution, installation, service, and technical support of medical devices.
The ISO 13485:2016 is the latest revision of the standard that contains substantial updates relating to risk-based quality processes, supplier management, and strict adherence to regulative necessities. ISO 13485 is one of the product standards developed by ISO that define guidelines for the manufacturers to follow to ensure a practical role in the fight against the spread of the virus.
We, at Finecert, have a team of highly-efficient consultants who are passionate about helping clients obtain their desired certification be it any type of ISO Certification such as, ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 13485, ISO 50001, ISO 39001, ISO 21001, ISO 22301, ISO 20001, ISO 41001, or CE Mark, HACCP and GMP certifications.
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The process of ISO Certification includes a few basic steps:
ISO 13485 is intended to be utilized by associations that deal with any medical-related materials, services, and products. The risk of contamination of medical devices is not only from improper conduct of the devices by people but also from raw materials, airborne particles, dirty machines, etc. Therefore, manufacturers of medical equipment and products must consider the prevention of risk of contamination of the device during the production process.
ISO 13485 applies to any type of organization in the medical field as it is designed to be used by organizations involved in any step in the process of the production and supply of medical devices such as the design, manufacture, installation, and services. It is the most significant and up-to-date standard for medical devices. Hence, any company that is keen on ensuring the safety of their medical devices can benefit from it. ISO 13485 applies to any organization in the medical field irrespective of its size. In fact, a medical-based company with a single employee can also obtain this certification.