e-Consulting

Medical Devices

All Regulatory Science Solutions
"Regulatory affairs Experts Caring to accelerate the time to market of your Medical Device"

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
PSUR for Medical Devices

Certification of Medical Devices (CE Marking)

  • CE marking of medical devices EU Regulation 2017/745 (MDR).

– Medical Devices
– Non-medical devices, Annex XVI MDR

  • CE marking of in vitro diagnostic medical devices EU Regulation 2017/746 (IVDR).
  • CE marking of SW as medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
  • FDA

Medical Devices Documentation

  • Technical dossier:

o MDR
o IVDR
o 510K – FDA.

  • Technical File Update – MDD adaptation to MDR (medical solutions, syringes, bronchoscope…).
  • Clinical evaluation plan and report
  • Risk Management (ISO 14971).
  • GSPR
  • Classification of Medical Devices and IVD Medical Devices.

Post-marketing

  • Post-Marketing Monitoring Plan (PMS).
  • Safety Reports for Class I products.
  • Post-Marketing Clinical Follow-Up Plan and Report (PMCF)
  • Periodic Safety Update Report (PSUR).
  • Market surveillance and control.

Quality systems and audits

  • QMS. ISO 13485 certification
  • Internal audits.

Regulatory Affairs

  • AEMPS prior operating license (manufacturer, importer, grouping).
  • Importation of Medical Devices.
  • CCPS Marketing and distribution communication license (medical device tenders).
  • EUDAMED and UDI.
  • Export certificates – free sale
  • Communications and procedures with competent authorities (AEMPS) and Notified Bodies.

Pre-Clinical and Clinical Research

  • Pre-clinical testing (EN 60601-1, EN 60601-1-X, EN 60601-2-X…)
  • Validation and verification of medical devices.
  • Clinical research.
  • Biological evaluation (ISO 10993-1).

FDA

  • Strategy for FDA approval
  • 510K technical dossier for FDA

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