Personal Information
Organización/Lugar de trabajo
Pamplona Area, Spain Spain
Ocupación
Deputy Regulatory Affair and Quality Director at iLine Microsystems
Sector
Medical / Health Care / Pharmaceuticals
Acerca de
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).
- Presentaciones
- Documentos
- Infografías
Devices Sponsor Information Day: 4A - Medical Devices - Audit assessments
TGA Australia
•
Hace 8 años
Devices Sponsor Information Day: 1 - Conformity Assessment
TGA Australia
•
Hace 8 años
TGA changes for Medical Devices in Australia
Joe Hage
•
Hace 9 años
Capsules as medical devices
Generic Pharma 2.0
•
Hace 13 años