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Clinical Services for Medical Devices
AKRN provides clinical consulting services compliant with ISO 14155:2020.
We have the expertise to set up and manage clinical investigations designed to demonstrate clinical safety and performance of a medical device for CE Marking.
We also provide optimized solutions to obtain post-market surveillance clinical data on commercialized devices.
We specialize in providing CRO solutions that balance quality, timelines, and budget using scientifically rigorous methods.
Clinical Investigation Planning
- Design, Planning & Optimization
- Site Selection
- Development Clinical Investigation Plan (CIP), Investigator’s Brochure (IB), Case Report Forms (CRFs), Informed Consent Form (ICF)
- Preparation of Monitoring Plan
- Ethics Committee Submissions
- Regulatory (Competent Authority) Approvals
Clinical Investigation Conduct
- Site Qualification Visits (SQV)
- Site Initiation Visits (SIV)
- Interim Monitoring Visits (IMV)
- Source Data Verification (SDV)
- Close-Out Visits (COV)
- Study Documentation Control
- Adverse Event (AE) Reporting
Statistical Design & Analysis
- Analysis Population
- Sample Size Calculation
- Development of Justifications Rationales, Plans and Procedures
- Data Entry and Collection | Development of CRFs
- Data Review, Database Cleaning, Data Queries
- Development of Plans and Procedures
Regulatory Services for Medical Devices
AKRN partner with MedTech companies to support them in the regulatory process towards a CE mark certification.
CE Mark Regulatory Services
- CE Mark Strategic Planning
- Preparation of Technical Documentation
- MDD to MDR Transition
- IVDD to IVDR Transition
- MDR Product Approval Requirements
- MDR GSPR Overview
- Product Classification
- Clinical Evaluation Reports (CER)
- Notified Body and EU Competent Authorities Contact
- Unique Device Identification (UDI)
- Registration of Economic Operators
Medical Writing for Medical Devices
Medical Writing and Clinical Reporting
Our extensive experience and therapeutic knowledge are valuable when preparing plans and reports essential for an optimal regulatory strategy. Our services are compliant with ISO14155:2020, MDR 2017/745, and MEDDEV 2.7/1 Rev 4 guidelines.
- Clinical Investigational Plan (CIP)
- Clinical Study Report (CSR)
- Clinical Literature Research and Reports
- Clinical Evaluation Report (CER)
- Summary of Safety and Clinical Performance (SSCP)
- Post Market Surveillance (PMS)
- Post Market Clinical Follow Up (PMCF) Plan