Billev Pharma East Ltd., is a consultancy company and your partner in ensuring compliance with legislation for Medical Devices and In Vitro Diagnostic Devices.

Our experts are providing services certified in accordance with ISO 13485 for:

• Establishment and maintenance of a quality management system for medical devices
• Post-market surveillance
• The establishment and/or managing vigilance activities
• Preparation of clinical evaluations
• Acting as a Person Responsible for Regulatory Compliance (PRRC)
• Acting as an Authorized Representative (AR) for medical device manufacturers located outside of EU

At MedTech Summit 2025 in Berlin, we present our full services designed to help companies bring safe and effective medical devices or in vitro diagnostics to market, including:

Transition from MDD and IVDD to the new Regulation (EU) 2017/745 (MDR) and 2017/746 (IVDR)

• MDR and IVDR gap analysis
• MDR and IVDR transition plan
• MDR and IVDR transition project support
• Preparation of technical file medical device documentation
• Audits according to ISO 13485 (lead auditor)
• Risk management
• Certification with notified bodies
• Preparation for MDSAP
• Software and ERP validations
• Support in clinical trials and evaluations of Medical Devices and In Vitro Diagnostic Devices
• PMS plan and report
• Setting up appropriate contractual arrangements and supervision

Visit our Booth #10.

With our expertise, we help you navigate regulatory challenges and achieve success in the medical devices / IVDs market.

Maximize Efficiency
Minimize Complexity
Achieve Excellence