The Bridge to European Experts
Our expertise includes safety and performance studies and post-market clinical follow up studies (PMCF). We can be your bridge to the key opinion leaders and surgical experts throughout Europe.
Clinical Services
Clinical Trial and Consulting Services
We have the expertise to set up and manage clinical trials designed to demonstrate clinical safety and performance of a medical device for CE Marking, as well as obtaining post-market surveillance clinical data on commercialized devices.
We specialize in providing clinical solutions that balance quality, timelines, and budget using scientifically rigorous methods.
Clinical Site Activation
- Clinical strategy and planning
- Study Design & Optimization
- Ethics Committee and Competent Authority Submissions
- Clinical Investigation Plan (CIP) Development
- Clinical Site Selection
- Clinical Site Management
Clinical Monitoring
- Qualification Visits
- Site Initiation Visits
- Monitoring Visits
- Source Document Verification
- Close-Out Visits
- Trial Document Handling
- Reporting of Safety Information
Regulatory Services
AKRN partners to support MedTech companies in this process through the following CE Mark Regulatory Strategy Services:
- CE Mark Strategic Planning
- Technical File | Design Dossier
- EU MDD to MDR Transition
- EU IVDD to IVDR Transition
- EU MDR Product Approval Requirements
- EU MDR GSPR Overview
- Product classification and registration of devices
- Clinical Evaluation Reports (CER)
- Notified Body and EU Competent Authorities Contact
- Unique Device Identification (UDI)
- Registration of economic operators
Medical Writing
Medical Writing and Clinical Reporting
Our extensive experience and therapeutic knowledge are valuable when preparing plans and reports that are essential for an optimal regulatory strategy.
- Clinical Investigational Plan (CIP) according to ISO14155:2019 and MDR 2017/745
- Clinical Study Reports (CSR)
- Clinical Literature Research and Reports according to MEDDEV 2.7/1 Rev 4
- Clinical Evaluation Reports (CER) according to MEDDEV 2.7/1 Rev 4
- Summary of Safety and Clinical Performance (SSCP) according to MDR 2017/745
- Post Market Surveillance (PMS) Plans
- Post Market Clinical Follow Up (PMCF) Protocols