We offer the best services in medical devices consultancy
We are committed to allocating the necessary means and resources to achieve the highest quality standards
What do we do?
Medical software
Our experts will explain how to make software development, usability and validation plans.
Marketing and registration
Marketing in other markets. Product registration Entry strategies in third countries.
Clinical assessment plans
Clinical assessment plan and performance assessment We look for the best clinical strategy.
Administrative formalities
Management of files with the Health Authorities. Registration with Eudamed. Contract review.
Quality management
Quality Management System ISO13485 and 9001. Internal audits: initial analysis and follow-up.
Technical Documentation
Complete technical documentation for obtaining the CE marking. Post market surveillance.
Clinical research
Clinical investigations, clinical performance, PMCF, pre-clinical, biological evaluation reports.
Non-medical end products
Production of technical documentation for the marketing of Annex XVI products and quality systems.
