- Consultation on Quality Management Systems (QMS) according to ISO 13485:2021
- Review of EU GMP compliance.
- Person responsible for regulatory compliance (PRRC) for SMEs.
- Network of International Cooperative Partners
- Support for Market Entry Strategies in an International Context
- Audit Preparation and Training
- Development of a Regulatory Strategy for Market Access
- Creation, Review, and Approval of Technical Documentation
- Preparation of Product Risk Management Files in accordance with EN ISO 14971
- SOPs in accordance with EMA Directives and ICH-GCP
- Clinical Evaluation
- Post-Market Surveillance (PMS) System Monitoring
- Periodic Safety Update Report (PSUR)
- Summary of Safety and Clinical Performance (SSCP) in compliance with MDR guidelines
- Clinical Evaluation Plan: Including literature research, strategies, and report preparation (CEAR) for medical devices.
- Study Protocol: Study-related documents according to ISO 14155, study report, and support for publications.
- Biocompatibility Activities: Planning and reporting according to the EN ISO 10993 series.
- Clinical study protocol (CSP)/ Clinical investigation plan (CIP) aligned with GCP and ICH E6 (R3)
- Clinical Study Reports (CSRs), Patient narratives
- Investigator's Brochures (IBs), Investigational medicinal product dossier (IMPD)
- Informed Consent Forms (ICFs), Patient Information Sheets (PIS)/Patient Information Leaflet (PIL)
- Common technical documents for EMA submission aligned with ICH M4 guidline (Clinical parts of module 2)
- Safety update reports
- Manuscripts for Peer-Reviewed Journals
- Abstracts and Posters for Conferences
- Case Studies and Reports, Post market clinical follow up procedures.
- User Manuals and Instructions for Use (IFUs)
- Standard Operating Procedures (SOPs)
- Compliance and Quality Assurance
- Audit Reports
- Quality Management System (QMS) Documentation
- Grant and Funding Applications
Project Management
- Coordination of Writing Projects
- Timeline and Budget Management
