ISO-13485-Certified-nebraska

Getting ISO 13485 Consulting in Nebraska (NE)

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What is 137+42?

Quality management standards start with ISO 9001, but they do not stay there. Getting ISO 13485 certified in Nebraska is a great example of this since it is required for every medical device company and especially manufacturers.

Companies from certain industries have to comply with extra quality management standards in order to achieve customer satisfaction or work around other aspects of the products and services offered. When it comes to medical devices, the truth is there is a very thin line in how many defective devices you can offer to the public.

ISO-13485-Certified-nebraska

Actually, if you can achieve the goal of making all the devices perform properly and be of high quality, you will be more than successful.

ISO 13485 is a standard that addresses the need of guaranteeing the safety and performance of each medical device by adding new measures and requirements to the quality management system of the company. Therefore, to comprehend the ISO a bit more, you can consider it to be ISO 9001 but with several medical device quality management requirements added to cover specific needs and goals.

Now, what is the biggest difference between getting ISO 9001 alone and implementing ISO 13485 for your medical device company? Definitely, the final results you will obtain for the public.

It has been proven that manufacturers that comply with the regulations in ISO 13485 are able to meet customer satisfaction easily and continuously improve their devices. But more importantly, they are able to offer safe products that will not put anyone in danger.

ISO 9001 is more of a customer satisfaction standard that even when it comes with safety requirements, they are not specific nor very detailed to guarantee such products like medical devices will be safe for anyone using them. This means that the best option is to comply with the regulations in ISO 13485 and guarantee that your company gets certified to demonstrate compliance, reliability, and your ability to offer the best devices.

At IQC The ISO Pros of Nebraska, we can assist you in implementing it and making sure you are able to go through auditing and certification without any issues. Or, if you prefer, our experts can train you to understand the ISO properly and deliver advice during your implementation.

Additional requirements of ISO 13485 for medical devices


Since you will work around the requirements for your medical device company, you need to be familiar with all of them before implementation. And this applies to both situations: if you decide to implement it on your own or to leave it to our experts.

With that said, the most relevant requirements are:

  • Documentation requirements for medical device files.
  • Work environment requirements.
  • Contamination control requirements.
  • Production requirements for cleanliness of products.
  • Production requirements for sterile medical devices.
  • Requirements for reporting to regulatory authorities.

Although they are not mandatory, they allow you to create a quality management system that suits your needs and goals. Therefore, we highly recommend complying with them and working on getting certified.

Our team at IQC The ISO Pros of Nebraska will be available for you no matter your specific location in the state.

IQC The ISO Pros of Nebraska can help you implement, train on, consult, and have your company and/or organization certified on the following ISO Certifications:

If you want to enjoy the above-listed benefits, contact IQC the ISO Pros of Nebraska, now. Our services are accessible in all of the below-mentioned cities: