ISO 13485, The Credibility of the ISO 13485 certification: Medical devices

The Credibility of the ISO 13485 certification: Medical devices

The Credibility of the ISO 13485 certification: Medical devices

Are you concerned about the credibility of the ISO 13485 certification?

As medical professional or medical devices public procurement officer, you must know whether the medical devices which you purchase lies under all the internationally recognized standards. So, you will be much worried about the verification process and the authenticity of the ISO 13485 certification. The reason to keep an eye on these certifications is that some of the non-verified and non-conformal devices will bring a significant impact on public health.

Medical devices will be diverse and everything must meet the proper and qualified international standards, and then only they will be qualified to get on board for public usage. Global quality services (GQS), which is the leading consulting firm for offering proper and appropriate ISO certifications to all medical device manufacturers, strives hard to make sure that public health is not affected by the usage of non-conforming medical devices. The medical devices that are qualified to use must represent the standards under which they are confirmed in detail. This is considered to be the most essential thing, as it will showcase to you a lot of difference between conforming and non-conforming devices.

And, how are they certified?

  • The medical devices are first produced by the manufacturers and the specifications are made according to the internationally recognized standards.
  • Then, the certification body confirms the manufactured medical devices under the requirements of ISO 34185 certification.
  • Once the manufacturers are approved by the certification body to produce the verified medical devices, the national accreditation body will go for a complete check as they are meeting all the qualified standards.

Most manufacturers wish to sell medical devices around the world! So, how can they achieve this?

Simply put, if a national accreditation body is one of the notified bodies like Global quality services, you can benefit yourself by getting the ISO 13485 certification for your medical devices that are tested and verified with all norms. Keeping in mind some of the important notes, you can examine and verify the certificate properly.

In the certificate, check if there is a logo of the certification body. Next to the logo, you’ll have the logo of the Global quality services, a unique certificate number, a proper reference for the standard of the manufacturer of the medical device, the expiry or the validity date of the certificate, and in addition to this you need to check whether it is from a management system or a product certification. You can also check the website of the accreditation body to ensure that the certification body is accredited to ISO 13485. You can easily do this by having the unique certificate number as a reference. Get some of the open-source links that are available in the search engine and do a complete analysis by looking into the entire database of the accreditation body.

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