CriTech Research, Inc.

CriTech Research, Inc. is a specialized software engineering firm focusing exclusively on the medical device industry. With headquarters in Saline, Michigan and an office in Costa Rica, the company has spent over three decades developing software and providing independent verification and validation services for regulated medical devices across all FDA classes (I, II, III) and IEC 62304 software safety classifications (A, B, C).

The company operates under ISO 13485:2016 certification and utilizes a proprietary IEEE-based Critical Software Development Process designed to meet FDA and EU requirements. CriTech's service portfolio spans software development, testing, risk management, cybersecurity, remediation, due diligence, and emerging technologies including AI/ML and digital health applications. The firm reports 100% first-time approval rates for both FDA and EU submissions.

CriTech has completed over 500 projects for clients ranging from global medical device manufacturers like Stryker, Abbott, and Becton Dickinson to early-stage startups. The company's technical approach emphasizes complete requirements traceability and compliance with standards including IEC 62304, ISO 14971, FDA CFR Part 820, and EU Medical Device Directive 93/42/EEC.

CriTech represents a specialized option for medical device companies requiring software engineering with deep regulatory expertise. The firm's exclusive focus on medical devices and proven track record with FDA and EU submissions makes it particularly valuable for organizations where regulatory approval is critical and first-time submission success is essential.

Companies should expect a process-oriented engagement emphasizing documentation, traceability, and compliance. The firm's ISO 13485 certification and proprietary development methodology provide structure suitable for both greenfield development and remediation of existing Design History Files requiring regulatory updates.

CriTech operates exclusively within the medical device sector, serving manufacturers across diagnostic equipment, surgical devices, therapeutic devices, and monitoring systems. The company's healthcare expertise centers on regulatory compliance for FDA and EU markets, with specific capabilities in IEC 62304 software lifecycle processes, ISO 14971 risk management, and cybersecurity for connected medical devices.

The firm's client portfolio includes major manufacturers in surgical equipment (Stryker), diagnostics (Abbott, Becton Dickinson), cardiovascular devices (Terumo, Zoll), and ophthalmology (Alcon), demonstrating breadth across medical device categories requiring safety-critical software development.

Medical device manufacturers developing Class II or III devices requiring FDA 510(k) or PMA submissions, particularly those prioritizing regulatory compliance and first-time approval success. Companies acquiring medical device portfolios needing Design History File reviews, and organizations developing Software as a Medical Device (SaMD) requiring IEC 62304 compliance documentation and independent verification and validation services.