Intended-use validation confirms and documents that a specific software application or system produces the intended or specified results. We develop and execute intended-use validation procedures for software-based tools used in the development and manufacturing of medical devices. We also offer this service for software contained within the device itself.
Good communication is essential in any health facility. We provide communications solutions for a variety of protocols, including Health Level 7 (HL7) — used for both hospital information systems (HIS) and laboratory information systems (LIS) — as well as:
|•Controller Area Network(CAN)
Traceability is a valuable feature in any software project or system. Our team provides traceability analysis of legacy systems, which allows you to identify any problems with the documentation. We also provide solutions for any problems we encounter.
21 CFR Part 11
Make sure your medical devices are fully compliant. CriTech provides services to ensure your systems meet Part 11 requirements. Our services help you create the detailed audit trail, security, and electronic signature features required by 21 CFR Part 11. We work with you to ensure these systems are documented and maintained in a validated state.
In the process of acquiring medical device companies or licensing their technologies, many of our customers have had challenges determining the state of the software’s compliance to FDA, European, and other worldwide standards. CriTech will examine the software’s design history file of the potential acquisition and provide a report on the compliance and completeness of the device’s software. If needed, we can perform a more in-depth and rigorous investigation into the quality of the software and its related documentation, including detailed reviews of software verification and validation. If required, we’ll perform additional testing to confirm the quality of the software.