Basics Things That You Need To Know About ISO 13485

Unlike other professions, the medical field has seen an enormous boom in the middle of a global pandemic. Across all aspects – from medical services, equipment, and especially medical devices – the number of consumers purchasing these things have dramatically increased.

As regular buyers of these products and services, it is crucial to know whether these things have gone through the appropriate quality controls and checks to determine whether they are fit for consumption. 

Medical devices, or items meant for the disease diagnosis, treatment, and prevention, must pass the standard for quality management called ISO 13485. Large and complicated devices such as pacemakers, pumps, ventilators, and more straightforward tools such as thermometers, syringes, and tongue depressors are examples of medical devices. 

If you’re unsure whether your device qualifies as a medical device, there are many resources available to help you find out.

What is ISO 13485?

ISO 13485 is the most popularly used standard for medical devices and their quality management. It is employed internationally and is issued by the International Organization for Standardization (ISO).

The ISO 13485 standard makes sure that medical devices, no matter how simple or complex, are safe for use and compliant with any regulations or laws, and of course, the needs of the patient. This certification is an essential credential because it keeps the patients and the medical professionals who use them safe from any possible harm or side effects. 

The European counterpart for this standard would be the EN ISO 13485. It is nearly identical to the former. However, to qualify for EN ISO 13485 certification, companies should meet additional EU-specific directives.

Who Needs ISO 13485 Certification?

This international certification is meant for organizations and entities that engage in the design, production, storage, distribution, installation, and servicing of items that fall under the category of medical devices. 

Other parties, like certification bodies, can also use this to aid their auditing process.

What Benefits Does ISO 13485 Certification Provide?

Aside from ensuring the patients’ and medical professionals’ safety, there are many benefits to acquiring an ISO 13485 certification. Below is a list of a handful of advantages you can get:

  • Legal Compliance

You can avoid hefty legal fees by complying with regulations and standards in your state or country.

  • Valid Credentials

Potential investors and buyers can easily verify your business against an internationally recognized body.

  • Better Reputation

An ISO certification looks good in the eyes of your stakeholders, patients, and medical professionals. Interested parties are more likely to trust your product or service if it is backed by strong and credible certifications.

  • Customer Satisfaction

Aside from safety, the ISO 13485 certification is founded on the quality management principle of customer satisfaction. Having an ISO certification also means that your product or service is something that guarantees satisfaction. 

Despite the trying times the world is facing, the medical industry has seen an expansion like no other. While keeping up with the times, the interested organizations should meet all industry standards and regulations. 

For devices used for medical purposes, it is critical to abide by these standards because many people’s safety is at stake. As a means to ensure security in this field, organizations and entities should meet ISO 13485 standards.

This provides a host of benefits for organizations that produce medical devices, such as safety, reputability, and credibility.


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