EXPERTS IN MEDICAL DEVICE SOFTWARE SINCE 1994
Specializing in Medical Device Software Development, Testing, Remediation, and Cybersecurity
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.
Our Company in Numbers
0Years of Experience
0%Submissions Approved by FDA/EU
“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!”
“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!”