We make it simple!
CONSULTING AND TRAINING
Years of Multidisciplinary Excellence
For over 20 years, we have been working in the medical device sector, gaining cross-disciplinary experience that covers design activities, control and optimization of production processes, regulatory compliance, implementation of quality management systems, and the design and implementation of post-market activities such as clinical investigations and clinical follow-up studies.
SERVICES
Medical Device and IVD Services
Enhance your skills and boost your awareness.
Clinical Investigations and Post-Market Data Collection
Full-service planning and management of clinical investigations or post-marketing data collection.
→
Artificial Intelligence in Medical Devices (Regulation 2024/1689 and ISO 42001)
Secure and effective integration of AI in medical devices.
→
Software as a Medical Device (SaMD)
Verification and assessment of compliance of Software as Medical Device.
→
Clinical Evaluation and Performance Evaluation Process (CEP/CER – PEP/PER)
Analysis of available data or generation of new data through the definition of an evaluation plan and the drafting of a report.
→
Biological Evaluation Plan and Report Drafting (BEP/BER)
Analysis of available data for the biological evaluation of a medical device.
→
Implementation and Maintenance of Quality Systems
Correct implementation and maintenance of a Quality Management System.
→
Audit
Internal audits, supplier qualification, distributors, importers, and representatives to ensure compliance with industry standards.
→
Training
Tailored training for individuals and companies on quality management, regulations, supplier qualification, and risk management.
→
Are you looking for an experienced and reliable CRO for medical device consulting?
We design and manage all phases of the clinical investigation through our team of highly qualified professionals.
Contact us for any consultancy or training inquiries, or simply to ask a question.
We will take care to address your doubts or requests. We will be your support to eliminate uncertainties in the complex regulation of quality management systems or regulatory affairs, or to solve specific issues.