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Clinical investigation
Let our experts support you in the design, conduct, and reporting of your clinical investigations in accordance with applicable regulations and standards such as the MDR and ISO 14155.
Expert support for your clinical investigations
Medical devices require a tailored approach when it comes to generating the required clinical evidence. Conducting a clinical investigation is demanding and our team of dedicated experts works closely with you to ensure the project's success. We support you in the design, conduct, and reporting of your clinical investigations in accordance with the internationally acknowledged ISO 14155 standard and other applicable regulations such as MDR and national requirements. Our teams are located in multiple countries across Europe.
The purpose of clinical investigations is to establish or confirm aspects of medical device performance and/or effectiveness that cannot be determined by analytical studies, literature or previous experience. The data from clinical investigations are used in the clinical evaluation to demonstrate compliance with the relevant safety and performance requirements with respect to the clinical performance and/or effectiveness of the medical device.
We have extensive experience with all types of clinical investigations including exploratory or feasibility investigations, pivotal investigations, and post-market clinical follow-up (PMCF). We can also support you with your clinical evaluations, as well as partnering with you to build the right clinical development strategy for your medical device. Whether you need support with a specific aspect of a clinical investigation or the entire investigation, we offer flexible services to suit your needs.
Our services cover:
- Clinical investigation 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 investigation 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.