Medical Devices

Strategy - service to market access 

 

Design and implementation of a QMS tailored to strategic objectives

 

Pre-qualification audit, supporting the ISO certification procedure – per request

Quality Management System maintenance

Internal audit

Device Classification

Communication with the Notified Body

 

Clinical evaluation, clinical trial

 

Consultation, preparation of clinical trials

 

Professional consultation about needs and possibilities

Investigational plan design

Clinical database, sample size determination

 

Regulatory Affairs

 

Consultation on-demand with the Regulatory Authority regarding submissions

Technical documentation, study documentation preparation, and submission

Communication with the Regulatory Authorities

Clinical Evaluation Report

 

Local Project Management

 

Dedicated project manager in contact with our partners and Regulatory Authorities

Coordinating the team of professionals in each project

Contract management with sponsors, investigators, and institutions

Supporting CRA's performance and monitor visits

 

Clinical trial

 

Professional consultation about needs and possibilities

Investigational plan design

Possible site selection and communication with sites

Preparation and management of the study protocol (English/Hungarian), Informed Consent Forms and participant Information Sheets according to Hungarian standards

Hungarian protocol summary preparation

Preparation and management of the documents of the trial application submission to the Hungarian Regulatory Authority and Central Ethics Committee

Amendment management, submission

Documentation, submission, and follow-up of Adverse Events

Preparation and submission of Periodic Safety Update Reports and Amendments if needed

Submission of End of Study and trial outcome reports

Patients' insurance management

Data management and biostatistics services according to regulatory requirements, and international guidelines

Electronic web-based data management system with monitoring function

Clinical database preparation, management

Biostatistical evaluation, data mining, statistical report writing

Accredited Phase I Unit

Several clinical sites available country-wide for multi-center studies

Clinical pharmacologists with various specializations

Qualified staff, laboratory

Outpatient clinics

Recruitment of trial population via healthy volunteer and patient database

 

Vigilance

 

Local contact to the Regulatory Authority Pharmacovigilance Department

Surveillance, submission of PSURs, line listings and local SUSARs

Literature monitoring

24 hours availability