Personal Information
Organization / Workplace
Pamplona Area, Spain Spain
Occupation
Deputy Regulatory Affair and Quality Director at iLine Microsystems
Industry
Medical / Health Care / Pharmaceuticals
About
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).
- Presentations
- Documents
- Infographics
Devices Sponsor Information Day: 4A - Medical Devices - Audit assessments
TGA Australia
•
8 years ago
Devices Sponsor Information Day: 1 - Conformity Assessment
TGA Australia
•
8 years ago
TGA changes for Medical Devices in Australia
Joe Hage
•
9 years ago
Capsules as medical devices
Generic Pharma 2.0
•
13 years ago