EXPERTS IN MEDICAL DEVICE SOFTWARE SINCE 1994

Specializing in Medical Device Software Development, Testing,
and Remediation

EXPERTS IN MEDICAL DEVICE SOFTWARE SINCE 1994

Specializing in Medical Device Software Development, Testing, and Remediation

Compliant Medical Device Software

CriTech Research helps to ensure your medical device uses rigorously tested, fully compliant software. We have been ISO 13485 certified since 2012. Our quality system, including our Critical Software Development Process, conforms to applicable FDA Part 820 and Part 11 regulations and IEEE, IEC, ISO, GAMP, and AAMI standards. We have a 100% first-time approval rate with both the FDA and EU.

We provide a variety of services, including Software Development, Software Verification & Validation, Software Remediation, Software Safety and Risk Engineering, and Due Diligence. CriTech is an acknowledged expert in helping companies remediate gaps in their Software Design History File.

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Submissions Approved by FDA/EU