Why Choose CriTech?

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).

Customer Testimonials

"Thank you for coming to our aid and helping us get the firmware documentation under control, restructuring/improving the firmware, and validating the firmware. The FDA raised no issues with the software package you provided us. Your team was highly engaged and accountable. You are a first-rate partner."

"Today we received 510(k) clearance from the FDA in relation to our new product. Your contributions played a key role in receiving the FDA's blessing. On behalf of our entire company - thank you very much for your outstanding support!"

"CriTech did a fantastic job on the project we outsourced to them! Budgetary and timeline targets were met - a rare engineering accomplishment. Communications throughout the project were excellent. The process worked just as it is supposed to. CriTech performed for us!"

"It's always great to work with CriTech! You're easy to do business with and your work is superior. Budgets and timelines have always been met."

“CriTech did an awesome job. Thanks for helping us complete our project! We will definitely use you again on future projects."

“I just wanted to convey to you how extremely pleased I am with CriTech’s work. Your team did a great job at resolving what seemed like an endless number of challenges. The information and tools supplied to you was minimal at best - you did an excellent job of navigating the speed bumps and getting the technical side of our project completed. I would not hesitate to recommend CriTech to other medical device companies.”

Customer Testimonials

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