Specialists in Medical Devices
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.
Medical Device Services
Enhance your skills and boost your awareness.
Clinical investigations
Design and execution of clinical investigations, preparation of statistical analysis, investigation report, clinical evaluation and data collection re-planning.
Medical Writing
Developing and writing scientific texts for clear, quality communication that gives value to the product.
Non-EU countries
Support in DM registration activities in non-European countries for marketing.
Audit
Internal audit services, supplier qualification, distributors, importers, and mandate holders to ensure compliance with industry standards.
Training
Customized 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.