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ISO 13485 Certification Consulting for Medical Device and IVD Manufacturers

ISO 13485 is the de facto standard for medical device quality management systems (QMS). We have been helping companies implement, audit, and get trained on ISO 13485 since it was introduced in 1996. Regardless of whether you are formalizing your first QMS or upgrading from FDA QSR, our phased approach will put you on the path to ISO 13485 certification.

How We Help

Let our QMS team answer these vital questions for you:

  • What is ISO 13485:2016 certification?
  • How do ISO 13485 and FDA regulations overlap?
  • What’s involved in implementing a new QMS?
  • How much does it cost to get certified to ISO 13485?

ISO 13485 Certification Opens the Door to Markets Worldwide

We deliver a harmonized QMS that meets US FDA, European, and other international requirements, including those of Australia, Brazil, Canada, and Japan. That’s important, because if your goals include selling outside the US and Europe, ISO 13485 is essential. The QMS we build for you will be ready to expand with you.

Let Our Experienced ISO 13485 Consultants Help You Achieve Certification

We have worked with thousands of medical device and IVD companies, from startups to multinationals. Experience has taught us that a “one size fits all” approach simply does not work. That's why we take a flexible, staged approach to ISO 13485 implementation, molded around your existing processes, internal resources, and business needs.

What distinguishes our approach is our focus on performance and conformance. We analyze your processes with the goal of improving them before they are standardized and documented. This approach may require some effort and planning at the outset, but the modest investment of time will pay off with improved organizational performance and tangible ROI. Our approach also maximizes your chances of attaining certification during a third-party ISO 13485 audit!


Already Have a QMS That Complies With FDA Regulations?

If you have a quality system that complies with FDA 21 CFR Part 820, we will first conduct a gap analysis to assess your current level of compliance with ISO 13485. This analysis will uncover opportunities for improvement and reveal how much time and resource effort will be required to merge ISO 13485:2016 requirements with your existing QMS. We will solidify the path forward as you prepare for your initial ISO 13485:2016 certification audit.

Let’s Get Started!

There's no time like the present to begin your journey toward ISO 13485 certification. Our QMS implementation and auditing teams are located in the US, Europe, Asia, and Latin America, so we have the resources to get started right away. Give us a call so we can learn more about your needs.

Provided below are a variety of practice related white papers, market updates and case studies.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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