Medical Devices and IVDs
As Medical Device regulations become stricter, we beat the challenges faced by innovators in getting the medical devices to market faster under all current regulations. We specialize in clinical evaluation and investigation of medical devices supporting innovators with all requirements for all risk classes of their device-Class I, IIa, IIb and III, including Post market clinical follow-up (PMCF). We want to help companies make their ideas reality. The Task Force Group works closely with our International Advisory Board that assures medical expertise truly throughout all therapeutic areas
Whether you are looking to achieve
- CE marking
- Determining the safety and performance of MD
- Post-market Clinical Follow-up (PMCF) study
- MD consulting
- AE and incidents
- Medical Device Regulation (Regulation (EU) 2017/745 (MDR)
- Medical device classification
- Development of a study design that proves the performance and safety of your product
- The sample size calculation to collect robust data
- Preparing an investigational plan
- Train your staff in the conduct of clinical trials with medical devices
- The selection of reliable investigators and cost-effective countries
- Preparing Clinical Evaluations
- Regulatory consultancy
- All other tasks which might help you to bring your product to the market.
We can support you
IVD Task Force
When it comes to the performance evaluation of your next in vitro diagnostic medical device (IVD), the IVD Task Force here at GCP-Service is ready to help. Unlike medical devices, in vitro diagnostic medical devices do not come in direct contact with patients thereby play to a different set of rules and regulations.
The EU IVD Regulation 2017/746 covers in vitro diagnostic medical devices and replaces the existing European In Vitro Diagnostic Medical Device Directive (IVDD 98/97/EC). This change in the EU IVDR is bringing about a complex legislative process that prioritizes patient safety but can seem like an administrative hurdle to those who have not had experience with this in the past.
Our IVD Task Force is composed of members from project management, regulatory affairs, data management, biostatistics, and clinical monitoring departments. With the combined expertise from these departments our task force guides sponsor through all steps of performance evaluation of their IVDs because such studies can no longer be conducted like a medical device study. Larger pharmaceutical companies may not take on small to medium sized IVD studies due to the fact that documents must be tailored to meet new IVDR requirements. At GCP-Service, our IVD Task Force is ready and eager to help. Our passion to help our clients bring their IVDs to market with specialized multidepartment expertise sets us apart from other CROs.