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Our Services

SERVICES

The experience gained over 20 years enables us to identify the key services to assist you in the compliance process.

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.

Regulatory Affairs

To achieve and maintain compliance with Regulation (EU) 2017/745.

Quality Assurance

To properly implement and maintain a quality management system

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.