We offer the best services in medical devices consultancy
Device Frame

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.

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