The regulatory landscape for medical devices and clinical trials involving medical devices is evolving in most countries. Increasingly stringent requirements have seen a rise in the number of trials subject to external audits and inspections, with the competent authorities not always returning a favorable assessment. While medical device trials resemble medicinal product trials in some ways, there are substantial differences which need to be considered.
ASSIGN has established a dedicated medical devices clinical trial group to provide you with expert support to navigate these challenges. We will help you adhere to regulatory requirements, reduce your development time and financial investments, thereby giving your product the best chance of commercial and therapeutic success.
Through continuous training and development of our staff, we can ensure that we are up to date on the latest requirements and guidelines, so you know your product and it’s development are in safe hands.
If you are planning to conduct a clinical investigation to complement the conformity assessment procedure of a class IIa, IIb of III device, you will benefit from our extensive experience in planning, conducting and reporting clinical trials. This will enable you to achieve your goal -be it initial CE certification or post-marketing surveillance- efficiently and in accordance with applicable laws and regulations.
Our expertise includes:
- Clinical trial design and Clinical Investigation Plan (CIP) development (in accordance with ISO 14155:2011 + Cor. 1:2011)
- Development planning, contact with relevant authorities
- Development and translation of Informed Consent Forms
- Statistical trial design, assessments, analysis and randomization
- Generation of case record form (paper or electronic) and clinical data management
- (Remote)Monitoring plan and clinical monitoring
- Submission to Ethic Committees and Regulatory Agencies
- Set-up and appointment of Data Monitoring Committees (DMC)
- Investigational site selection and qualification
- Serious adverse events, serious adverse device effects and device deficiencies reporting procedure
- Clinical investigation report generation and submission
- CE-marking regulatory support