Our experts will explain how to make software development, usability and validation plans.
Marketing in other markets. Product registration Entry strategies in third countries.
Clinical assessment plan and performance assessment We look for the best clinical strategy.
Management of files with the Health Authorities. Registration with Eudamed. Contract review.
Quality Management System ISO13485 and 9001. Internal audits: initial analysis and follow-up.
Complete technical documentation for obtaining the CE marking. Post market surveillance.
Clinical investigations, clinical performance, PMCF, pre-clinical, biological evaluation reports.
Production of technical documentation for the marketing of Annex XVI products and quality systems.
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