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Pamplona Area, Spain Spain

Deputy Regulatory Affair and Quality Director at iLine Microsystems

Medical / Health Care / Pharmaceuticals

Consulting and Auditing services in Medical Devices (IVD Sector). - FDA Premarket applications for Medical Devices (510k, Device Registration and Listing) - Qualitys Systems (ISO 13485:2003, ISO 9001:2008), - Medical Device Legal Requirements: (Directive 98/79/EC, Directive 2007/47/EC, REACH), - Software (IEC 62304), - Risk Management (ISO 14971:2007), - FDA Quality System Regulation (21 CFR Part 820).