Getting ISO 13485 Certified-ISO 9001 Austin TX-ISO PROS #27

Getting ISO 13485 Certified in Austin, Texas (TX)

How do you know a medical device will meet its function and purpose without issues or problems? The only way to guarantee there won’t be problems with a medical device we all know is of great importance is to ensure that the company and manufacturer providing it follows the right standards. In the medical and health industry, several ISO standards are mandatory instead of optional.

You will notice it right after joining the industry or even when trying to research about it to consider the idea. This industry has several aspects and elements to cover in order to ensure the best quality products and services from any company and organization that provides them. And for this, a couple of ISOs will be more than necessary. In the case of manufacturers and businesses that fabricate medical devices, they have to meet all the requirements in ISO 13485.

This standard has all the parameters and guidelines to establish, maintain, and improve its Quality Management System and always guarantee high-quality devices. This ISO comes from the standard 9001, which is considered to be the head of the family of these normative or standards. However, it has several additional requirements to meet and you will notice how focused it is on every part and section of medical devices. Yes, ISO 9001 is crucial and something you will hear and read about a lot, but for medical devices manufacturers, ISO 13485 will be part of the group of standards they can’t and shouldn’t ignore.


When you are familiar with a normative or several ones, the process of implementing this one won’t be as difficult as before. But if you need support and assistance in conducting this process, just make sure to contact us at ISO Pros. Our company is a validated and qualified ISO organization that has been providing consulting, training, support, and implementation services for over a decade.

We are part of the few validated companies in Austin and all Texas that can help you with the implementation and training, and not only provide a seal of approval.   We will make sure you meet all the requirements so your company can enjoy every small or big benefit. Most of the time, medical devices manufacturers contact us to handle the entire process for them, and this is completely fine.

Some companies that are trying to implement this ISO usually have a hard time trying to get certified after the implementation as well. And here is when we also play an important role. We offer even more our services when you don’t meet all the requirements and need some assistance to restart or go over the entire implementation process again.

Where do we offer these services? Austin isn’t the only city in Texas we cover with our certifications. We have several experts and offices around the state that will be there depending on your location and of course, needs. Therefore, there is no need to worry: be it Austin or any other city in Texas.