Clinical performance study
Our experts can help you in the design, conduct, and reporting of your clinical performance studies in accordance with applicable regulations and standards such as the IVDR and ISO 20916.
Supporting your clinical performance studies
Generating clinical evidence for your in vitro diagnostic (IVD) medical device requires a tailored approach. We can support you in the design, conduct, and reporting of your clinical performance studies in accordance with applicable regulations and standards such as the IVDR and ISO 20916. Our teams operate across several countries in Europe.
The purpose of clinical performance studies is to establish or confirm aspects of IVD medical device performance that cannot be determined by analytical performance studies, literature or previous experience gained by routine diagnostic testing. The data from clinical performance studies are used in the performance evaluation to demonstrate compliance with the relevant safety and performance requirements with respect to the clinical performance of the IVD medical device.
Our experts have experience with different types of clinical performance studies including exploratory or feasibility investigations, pivotal investigations, and post-market performance follow-up (PMPF). In addition to clinical performance studies, we can support your performance evaluations and collaborate with you to design the optimal clinical development strategy for your IVD medical device. We offer custom solutions that meet your unique needs – from managing different aspects of your clinical project to full clinical study management of the entire study.
Our services cover:
- Clinical performance study start-up, including feasibility assessment and site evaluation
- Clinical project management
- Monitoring and site management
- Regulatory submissions to competent authorities and ethics committees, including preparing the submission package
- Medical writing to prepare e.g., the clinical performance study plan/report and literature reviews
- Data management and biostatistics
- Vigilance
- Outsourcing services for when you need extra resources/interim solutions
- Quality and regulatory services
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Explore our services
Clinical investigations
Support in designing and conducting your clinical investigations in accordance with applicable regulations and standards, e.g., MDR and ISO 14155.
Clinical performance studies
Support in designing and conducting your clinical performance studies in accordance with applicable regulations and standards, e.g., IVDR and ISO 20916.
Clinical operations
Our experienced teams can help you plan, design and conduct your clinical studies from start to finish.
Regulatory strategy
Market registrations
Digital health and cybersecurity
Technical documentation
Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Clinical evaluation
Proven expertise in planning and conducting a thorough clinical evaluation that supports the regulatory approval of your medical device.
Performance evaluation
Dedicated experts in planning and conducting a thorough performance evaluation that supports the regulatory approval of your IVD medical device.
Biological evaluation
We support you in planning and conducting a thorough biological evaluation of your medical device that is compliant with ISO 10993-1.
Risk management
Medical device risk management services for setting up and maintaining your risk management process and helping you prepare your documentation.
Usability engineering
Support for your usability engineering activities, from creating a process to preparing a usability engineering file for your medical device.
Due diligence
Quality and regulatory experts ready to support your due diligence projects with comprehensive appraisals of medical device businesses.
Person Responsible for Regulatory Compliance (PRRC)
Our experts can support you in understanding the full range of PRRC responsibilities.
Quality management system services
QMS services for medical device manufacturers to help you design, implement and manage your QMS to support your organization's needs.
US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
Auditing services
Improve your quality management system with our internal auditing services for medical device manufacturers.
Post market surveillance
Post market surveillance services to help you systematically gather and analyze data on the quality, performance, and safety of your medical device.