Services

We offer the best services in medical devices consulting.

We are committed to allocate the necessary means and resources to achieve the highest quality standards.

CLINICAL EVALUATION PLANS

<p>Clinical assessment plan and performance evaluation. We seek the best clinical strategy.</p>

QUALITY MANAGEMENT

<p>Quality Management System ISO13485 and 9001. Internal audits: initial analysis and follow-up. </p>

TECHNICAL DOSSIERS

<p>Complete technical documentation for obtaining the CE marking. Post market surveillance. </p>

MARKETING AND REGISTRATION

<p>Commercialization in other markets. Product registration Entry strategies in third countries. </p>

NON-MEDICAL PRODUCTS

<p>Preparation of technical documentation for the commercialization of Annex XVI products and quality systems.</p>

QUALITY AND REGULATORY TRAINING

<p>Comprehensive training in regulation and quality management systems for companies and managers.</p>