Why Choose CriTech?

CriTech has focused on medical device product quality and patient safety for over 30 years.

We help customers get their medical device products to market. With more than three decades of experience developing software and delivering independent software verification for regulated industries, our process is proven. Our knowledge is current. And our team is highly responsive to you.

CriTech is ISO 13485:2016 certified and utilizes our IEC 62304 compliant, IEEE-based Critical Software Development Process, which is designed to develop and test software to ensure it meets the requirements of the FDA and EU.

Our proven proprietary software process conforms to applicable FDA, EU, IEEE, IEC, ISO, GAMP, and AAMI standards.

CriTech’s services support 510(k) and PMA submissions.

First-Time FDA Approvals
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First-Time EU Approvals
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of Medical Devices in Market
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Our deep understanding of the medical device industry has resulted in FDA approval and European Union CE Mark for hundreds of devices from all FDA classes (I, II, III) and IEC 62304 software safety classifications (A,B, C).

A Highly Responsive Team

If you are looking for a team that is dedicated to excellence, innovation, and compliance, think CriTech.

We are here to help you achieved your goals and bring your medical device software to market with confidence. Contact us today to learn more about how we can help you. Let us make remarkable things.

Customer Testimonials