The diversity and innovativeness of the medical device sector contribute significantly to enhance the quality and efficacy of healthcare.
Covering a wide range of products, from simple bandages to the most sophisticated life-support products, the medical device sector plays a crucial role in the diagnosis, prevention, monitoring and treatment of diseases and the improvement of the quality of life for people suffering from disabilities.
Evolving regulatory requirements
The European regulatory environment for medical device clinical trials has changed significantly. All implantable and combination medical devices require clinical research data to obtain the CE Mark (official mark of consumer safety in the European Economic Area).
Accovion can help you conduct your medical device development on the right pathway. We can help ensure that the clinical development of your product conforms to all the relevant safety and health requirements outlined in the EU medical device legislation.
Evidence for your product
To provide the evidence for your notified body and competent authorities, Accovion offers:
- Protocol planning and feasibility
- Assistance in obtaining ethical and legal approval
- Material logistics
- Compliant and efficient trial conduct
- Appropriate monitoring
- Data capture technology
- Risk assessment
- Clinical evaluation
- Statistical analysis
Ethical and safety considerations
Accovion applies specific procedures for conducting clinical investigations of medical devices that will:
- Protect human subjects
- Ensure proper scientific conduct in the clinical investigation
- Assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in assessing medical device conformity
When you choose Accovion as your clinical development partner, you will have access to dedicated and qualified medical device clinical research sites, especially for indications such as orthopedics, surgery, trauma, cardiovascular, neurology, pain therapies, thrombosis and prophylactic treatments.
Accovion is a proud sponsor of the AFOR (Association for Orthopaedic Research)
We’ll help you design and implement a clinical trial that best meets your needs, whether you need clinical data to support a regulatory pre-market submission, drive product adoption, support product reimbursement or monitor post-market product use.