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The world of Medicine and Medical Devices is so crucial and critical that it needs to be standardized so that all processes and policies are uniform worldwide. Through this, the Medical Devices Standard, otherwise known as the ISO 13485 has been established and published by none other than the International Organization for Standardization (ISO).

So is the Medical Devices Standard applicable to all apparatuses and technologies in the medical field? Or is it only for a specific practice or discipline? What is ISO 13485 in the first place?

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Medical Devices ISO 13485-IQC ISO9001

What is the ISO 13485?

The ISO 13485 or the Medical Devices Standard is the standard that discusses and specifies the requirements for Quality Management Systems (QMS). It’s the standard by which a company or an organization would have to show its capability and ability to produce and manufacture Medical Devices as well as related products and services.

With this standard, companies, and businesses under the practice are given a set of requirements they need to at least meet should they want to have appropriate and proper certification.

ISO 13485 handles and tackles everything from the planning, the designing, the production, distributing – even the installing of Medical Devices.

Quality Over Quantity

Many business owners and executives would repel, but what the ISO 13485 would like to prove is the fact that it values the quality more than the quantity. For instance, if a company or an organization is able to produce a thousand units of one medical device and about 60% of them is malfunctioning, it’s never better than a company that produces 400 units with 1 to 2% defects.

And if you are wondering where you can get an ISO 13485 Certification – then you can get it none other than here with us at IQC – the ISO Professionals. Across the entire state of New Jersey, we’ve been deemed and considered by many of our clients as the most reliable, the most technical, and the most urgent ISO Auditing and Certification company.

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Benefits of Working With Us

But how are we named and deemed as the best? What qualities do we have that other companies and organizations don’t? Through our never-ending plans of improvement and development; and the perseverance we have in the industry, our clients see how we value them and their business.

In fact, here are some of the advantages if you choose us as the company that can provide the ISO 13485 Certification that you wish for:

  • Expert Advice and Consultation on the Medical Devices Standard
  • Safe and Secure Precautionary Measures
  • Better and More Frequent Employee Involvement and Engagement
  • Lower and Cheaper Costs and Rates
  • And Many More!

Whether you’re in the manufacturing industry, or if you’re on the lighter side of the distribution and packaging, getting the Certification in the ISO 13485 standard would mean a lot for your business and how it establishes trust and connection with its market and its clients.

Never miss out on an opportunity to work with the best here at IQC – the ISO Professionals!

We service multiple cities throughout the state of New Jersey. We provide all the services listed below and more in every city.

If you don’t see your city listed, don’t worry. Just contact us by giving us a call or filling out the form, and we’ll dive deep to discover what are the best solutions for you and your business. See our areas of service:

We operate nationwide without any type of restriction – wherever you are, you can feel free to contact us.
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