Advice for the legal compliance of medical devices.

Servicios que ofrecemos:

  • ISO 13485 implementation.
  • Product risk management.
  • Licensing of manufacturer, importer, steriliser or grouper.
  • Product qualification and classification.
  • Product registration.
  • Obtaining CE marking.
  • Review of advertising.
  • Communications of distribution in the Autonomous Community.
  • “In House” products.
  • Preparation of technical dossiers for medical devices and in vitro diagnostics.
  • MDSAP implementation.
  • Clinical and performance evaluation.

We perform value-added audits:

  • Internal audits (1st part).
  • Supplier audits (2nd part).
  • Integrated management system audits.
Persona en un laboratori

Training:

• Open courses organised in INGECAL.
• Courses and seminars “in company”.
• Online courses available on the e-learning platform INGECAMPUS.

Have you heard of our IMDC?

Project Manager

  • Ana Fernández
    Ana Fernández Director of Corporate Development and Project Manager: Medical Devices, Healthcare and Pharma-Cosmetics

    Graduate in Chemical Sciences.
    Diploma in Operations Management – EADA.
    Master in Business Administration – The Power MBA.

Contact us

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Thank you very much.

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