Medical Devices
Effective and efficient support to meet the marketing standards in place for Medical Devices, Software and IVDs at any stage of the product life cycle.
Azierta 360º Medical Device Projects
Versatile and Strong Expertise.
- Strategy
- Design & Engineering
- Regulatory & Compliance
- Our experience -
- Technical File update and adaptation from MDD to MDR (medical solutions, syringes, bronchoscope…)
- Technical Files and classification (Medical software, indicator meters in blood, Software, pulse oximeters, medical kits software and devices, internal sutures, reusable surgical material, resuscitation system…)
- SGC & AEMPS License (indicator meters in blood, catheters…)
- CCPS Communication and distribution License (Medical devices tenders)
- Technical File for CE mark and 510K for FDA (Several medical devices, communication equipment, biocides for cleaning of medical devices…)
- Support in the preparation of contract with subcontractor
- Import license for Medical Devices (Syringes, surgical cotton, internal sutures…)
- Distribution License for Medical Devices
- Clinical Trials at any stage from pre-clinical to post marketing
- Vigilance, PSUR
- Risk Assessment and Feasibility Analysis
- ISO 13485 certification QMS
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