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Build compliant software with help from CriTech Research. Headquartered in Saline, Michigan, we specialize in software testing, development, and remediation for medical device applications. CriTech provides custom solutions tailored to meet your specific software engineering needs.

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Independent Verification and Validation (IV&V)

CriTech provides a variety of software testing services, from development of plans, designs, test cases, and procedures to actual test execution and reporting. We offer complete independent verification and validation of the software for your product.

Throughout the testing, we follow an IEEE compliant verification and validation process that results in documentation that aids technology transfer to the customer at the end of the project. The products we have worked on have consistently achieved 100% first-time approval from both FDA and EU Notified Bodies.

Software Remediation

CriTech is an acknowledged industry expert at helping companies remediate gaps in their software Design History File (DHF) and Technical Files (TF). Our services include reverse engineering of requirements and complete verification and validation of designs. We have successfully remediated more than 100 products with challenged software Design History Files or Technical Files. Each of our remediation efforts received first-time approval from the FDA and/or CE Marking Notified Body. Our diverse skill sets and techniques combined with our knowledge of required processes and tools allow us to execute remediation projects in the most efficient manner. We give you the best chance to bring your product's Design History File or Technical File up to standard effectively and without worry.

Software Safety Engineering

When it comes to medical devices, safety is critical. We utilize fault tree analysis (FTA) based on customer's failure modes and effects analysis (FMEA) to discover and evaluate software safety faults.

Software Development

From initial development to project management, we do it all. CriTech takes a high-level set of system or software requirements for a product and creates safe, reliable software that meets your needs. During development, our project management plans and regular status reports provide visibility into each of the activities required for successful software development. At every phase of the project, our critical software development process (CSP) provides detailed guidance for all development activities, including:

• Project Management
• Quality Assurance
• Configuration Management
• Engineering
• Safety Engineering
• Verification & Validation

Mobile Medical Applications

The world is going mobile. Don't get left behind! CriTech develops and tests mobile medical applications (MMA). For Apple™ iOS platforms, we use Objective-C programming languages in the X-Code development environment. For Google™ Android™ OS, we utilize Java™ in Android Studio™.

Intended-Use Validation

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.

Communications Development

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)
•Ethernet Networks
•Bluetooth™ Networks
•DeviceNet Networks
•IDB Networks
•Proprietary Networks

Requirements Traceability

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.

Due Diligence

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.

We specialize in software verification and validation for medical devices.