Schedule with Booking 

YOU CAN SET UP YOUR OWN CALENDAR WITH OUR BOOKING TOOL, AND SCHEDULE APPOINTMENTS TO A RANGE OF DIFFERENT BUSINESS MARKETS.

Clinical Evaluations

UNPARALLELED EXPERTISE IN CLINICAL EVALUATIONS REPORTS: GET YOUR PRODUCT TO MARKET FASTER

We offer comprehensive solutions for your medical device's clinical evaluation needs, ensuring compliance with international standards and specific regulatory requirements across all markets.

Complete Clinical EvaluationsOur team can guide you through the entire clinical evaluation process, from developing a customized Clinical Evaluation Plan (CEP) to generating the final report.

We leverage established scientific methodologies, including systematic reviews and meta-analysis, to gather and analyze the most relevant evidence supporting the safety and efficacy of your device.

Partial Clinical EvaluationsFor medical devices in the early planning or development stages, we offer a tailored service that identifies potential equivalents for your device. Through a thorough research process, we locate existing scientific evidence demonstrating the safety and effectiveness of these equivalents for each intended use case.

This proactive approach helps mitigate the risk of encountering unexpected clinical investigation requirements, lack of suitable equivalents, or insufficient data for registration by equivalence later in the development cycle.

Valuable insights from the partial clinical evaluation can then be seamlessly integrated into the complete clinical evaluation report, streamlining the overall process and potentially reducing time and investment needed to bring your product to market.

Benefits of Clinical Evaluation

Expert Guidance
Leverage our team's deep understanding of international standards and regulatory requirements.

Scientifically Rigorous Approach
Ensure the highest quality clinical evaluation based on established methodologies.

Streamlined Process
Reduce time and costs associated with market entry.

Proactive Risk Mitigation
Identify potential roadblocks early in development.

CONTACT US TODAY TO DISCUSS YOUR SPECIFIC CLINICAL EVALUATION NEEDS AND LEARN HOW WE CAN HELP YOU ACHIEVE SUCCESSFUL MARKET AUTHORIZATION.