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ServiceUpdated on 20 July 2026

Strategic consultancy for medical devices

CEO AMConsulting Medical Devices S.L. at AMConsulting Medical Devices

Madrid, Spain

About

Regulatory & Quality Strategy for MedTech & IVD: Turning regulatory complexity into confidence, quality and growth.

  • Post-marketing service

  • Preparation of registration documentation  (Technical File)

  • Risk Management and Analysis (EN ISO 14971)

  • Communications with Notified Bodies and Health Authorities

  • Biocompatibility Plan and Report

  • Clinical Evaluation Plan and Report

  • Advice on labeling and promotional materials

  • Support for the selection of the Notified Body

  • Medical Device Software (MDSW)

LET US JOIN YOU IN YOUR  JOURNEY TO THE REGULATORY EXCELLENCE

Type

  • Consulting

Applies to

  • Health innovation
  • Digital health

Organisation

AMConsulting Medical Devices

Consultancy

Madrid, Spain

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