How Does ISO 13485 Affect Your Company’s Ability to Do Business?

February 13th, 2014 by

ISO 13485 ComplianceAlthough medical device manufacturers have to adhere to a number of pertinent regulations to access foreign markets, there are some that stand out amongst the others. ISO 13485 is one such standard, and many firms strive to attain compliance with it.

Why ISO 13485?

For many medical device manufacturers, compliance with ISO 13485 is one of the first steps in marketing products within the EU. Before EU regulators permit sales of a specific device, it must demonstrate compliance with a number of EEC mandates and directives.

Many firms prove their products are compliant by earning Quality Management System certifications according to ISO 9001, ISO 13485 and ISO 14971. They can then earn the CE mark and gain permission to sell their products in the EU.

What Does ISO 13485 Address?

ISO 13485 is specifically geared towards medical device providers that need to implement quality management systems to validate their products. As the standard’s abstract notes, it excludes some of the requirements found in other standards.

Although this rule doesn’t include the continual improvement prerequisite of ISO 9001, it remains difficult to obtain and maintain. Compliance with the processes it requires is entirely the responsibility of the manufacturer, and firms need to prove their regulatory adherence before marketing new products. For strategies and suggestions on how you can accomplish this goal through training your company’s staff, click here.

Comprehensive Compliance

Don’t let the importance of ISO 13485 fool you into thinking that it’s the only standard you should be concerned with. While it’s prudent to focus on specific guidelines and regulations in order to reach new markets, it’s even more important to create an overall quality management system that can be fine-tuned to a variety of purposes.

Working with a compliance consultant is a good way to maintain manufacturing processes that you can adapt. As time goes on and standards like ISO 13485, FDA CFR 21 and ISO 9001 grow in scope, it’s nice to have the assistance of an impartial consultant that can help you modify the way you operate in turn.

GxP-CC has extensive experience in compliance consulting for EU and FDA regulations for the medical device, pharmaceutical and dental lab industries. Contact them to discuss how they can help you business achieve and maintain compliance.



About this author:


For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

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