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Our Services
Regulatory Compliance (MDR and IVDR)
Clinical Strategy - Pre- and Post-Market Data
Quality management systems and outsourcing
Do you need to implement, improve, or simply monitor a quality management system? Do you want to outsource the Quality Assurance function ?
Software and AI
Global Market Access Decision
Clinical Evaluation and Clinical Performance (CEP/CER - PEP/PER)
Biological Evaluation (BEP/BER)
Audit
Clinical Surveys
Design and execution of clinical investigations, processing of statistical analysis, report of the investigation, clinical evaluation and re-planning data collection.
Medical Writing
Developing and writing scientific texts for clear, quality communication that provides value.
Extra-EU Countries.
Support in DM and IVD registration activities in Extra-European countries for marketing.
Regulatory Affairs
To achieve and maintain compliance with Regulation (EU) 2017/745 and (EU) 2017/746.
Audits
Internal audit services, qualifying suppliers, distributors, importers and agents to ensure compliance with industry standards.
Training
Customized training for individuals and company on quality management, regulations, supplier qualifications, risk management.