Strategic Approval Services

Support in every stage of the technology lifecycle approval, maximizing compliance, performing correct tests, avoiding unnecessary trial and saving time and money.

CE Mark Roadmap

Our integrated team of medical writers, biostatisticians, regulatory specialists, and clinical experts working all over Europe, will support you in conducting your clinical trial by analyzing and interpreting data and ultimately packaging your trial to obtain an expedited CE mark.

Risk Management

Having difficulties in maintaining your clinical trials compliant with ISO 14071? Meditrial makes it easy. With our global experts we will guide you through all the steps for a successful implementation of a risk-management process.

Clinical Evaluation

Guarantee the clinical safety and performance of your medical device thanks to our highly specialized team work. We shall carry out the assessment and analysis of clinical data pertaining to your clinical device.

Meditrial CER for CE Mark

  • CLINICAL EVALUATION REPORT (CER) is essential to obtain the CE Mark based on a scientifically solid methodology.
  • The same report can be used for due diligence, FDA submission and global regulatory approvals in other countries.
  • Meditrial CERs have gained approval for 100+ Innovative devices, including high risk class III products involving software, hardware, animal tissue, drug combination and more.

The Meditrial Academy training program allows easy understanding of the steps to produce the CER and superior collaboration.

Post Market Surveillance

Make it simple. Trust our experts in meeting post-market surveillance (PMS) requirements to guarantee compliance with international and harmonized standards in observance with all applicable regulations regarding the European Medical Devices Directives.