Medical Device Testing Solutions | Veranex iCRO

Medical Device Testing Expertise for Safety and Compliance

Successfully bringing a medical device to market demands a proactive approach to safety and compliance that begins in the earliest design phases.

Our teams integrate specialized expertise to guide you through biocompatibility, electrical safety (EMC), and sterilization requirements to develop a robust testing strategy and manage the execution with qualified medical device testing laboratories to ensure it is executed flawlessly. This integrated approach ensures that material, electrical, and reprocessing compliance are addressed from the start, safeguarding patient safety and streamlining your path to a successful regulatory submission.

Toxicology and Biocompatibility Testing for Medical Devices

Navigating the requirements for biocompatibility and toxicology is critical early in the design process for a data-proven safe device that is ready for submission. We provide expert consulting to help you develop a comprehensive testing strategy based on your device's materials and intended use, manage qualified lab partners, and interpret study results to satisfy global regulatory requirements.

Biocompatibility Services

Electrical Safety and EMC Testing for Medical Devices

We guide your product through the complexities of electrical safety and electromagnetic compatibility (EMC) requirements, weather electrically-driven medical devices or an IVD. Our experts provide end-to-end support, from risk analysis and standards interpretation to formal testing and certification management, ensuring your device meets global standards for market entry.

Key Areas of Expertise:

Training and implementation support of requirements per regulatory standards
CB scheme and/or NRTL testing plans
Test laboratory selection, depending on intended global market access strategy

Reusable Device Cleaning and Sterilization

We provide expert guidance on the cleaning, disinfection, sterilization, and reprocessing for your medical devices.

Key Areas of Expertise:

Select the appropriate methods
Determine required assessments based on applicable standards and regulations
Develop a process strategy
Define validation plans
Develop and review of technical documentation, including instructions for use
Analysis and interpretation of test results
Management and support with all medical device laboratory testing labs and regulatory stakeholders involved

Plan and Execute Accordingly with Built in Expertise

Integrating quality at every phase of the device lifecycle assures patient safety and allows devices to stay on the market.

Discover More

Additional Integrated Services for All Your Medical Device Testing Needs

Bringing a medical device to market successfully requires more than a powerful vision; it demands flawless, integrated execution. Our services are built on the Innovation CRO (iCRO) model, providing you with a single, dedicated partner to unify every stage of development and turn that vision into a commercial reality.

Functional and Verification Testing

We confirm that your product is built to specification and performs its intended function reliably through rigorous verification testing. Our team produces traceable units that generate the robust data needed to de-risk your submission and support any design changes with confidence.

Testing Capabilities

testing-r-1

Usability and Design Validation Testing

We design and execute formative and summative usability studies to ensure your device is safe, effective, and intuitive for its intended users. Human factors testing is a critical component of your design process and a key requirement for a successful regulatory submission.

Human Factors_500x500

Preclinical Testing and Consulting

Experts full-service preclinical testing, from early proof-of-concept studies to final GLP-compliant reports for regulatory submission. We design and execute studies that demonstrate the safety and biological effectiveness of your innovation, de-risking your product and building a strong foundation for clinical success.

Gen PCS related services_500

Clinical Study Design, Support, and Execution

Strategic partnership for your clinical trials, supporting you from initial study design and trial plan execution to interactions with regulatory agencies, ensuring the human data you collect is efficient and powerful enough for your market application submissions.

Medical Device CRO_500x500

Bob-Bouthillier

Bob Bouthillier

Director, Electrical Engineering

Monica Grekula

Sr Director, Biocompatibility and Toxicology

Naghmeh Nouri

Executive Director, Quality Engineering

Elevate Your Medical Device Testing Strategy & Execution

Getting a device to market requires both comprehensive strategy and successful execution. Partner with our experts to design your integrated testing plan and manage its implementation, ensuring a compliant and clear path to market.

Partner with Veranex