Why Choose CriTech?

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

Our 30+ years of expertise developing software and delivering independent software verification for regulated industries has made us successful in helping our customers get their medical device products to market.

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.

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.

  • Our Understanding

    Our understanding of the needs of the medical device industry has resulted in FDA approval and the European Union CE Mark for hundreds of devices from all FDA classes (I, II, III) and IEC 62304 software safety classifications (A,B, C).

  • Our Incredible Success

    Our work has a 100% first-time acceptance rate from the FDA and EU

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.”

Vice President

Quality

“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!”

CEO

Company

“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!”

Vice President, Research & Development

Company

“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.”

Medical Device Software Manager

Company

We look forward to talking with you!

We are ready to assist in getting your medical device software compliant and can start at any point during your life cycle process!

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