MEDICAL DEVICES

Medical Devices have an increasingly important role in the health sector.

MEDICAL DEVICES

Medical Devices include, in a simplified form, all products used in health care that are not medicines, of very different nature and purpose: equipment used to correct deficiencies, diagnostic equipment, active or non active implantable devices, equipment and medical surgical instruments, diagnostic reagents or software used in healthcare.

We offer consulting services that comprise continuity over time and strategies to comply with local requirements:

  • Registration of Responsible Company for placing a product in the Spanish market.
  • Notification of medical devices through IT application in the Spanish Agency.
  • Review of advertising and publicity.
  • Audit and design of facilities of distribution, import and manufacturing.
  • Request of authorization for manufacturing and import Medical Devices.
  • Request of CE mark.
  • Contacts with Notified Body in Spain.
  • Vigilance of Medical Devices.
  • Request of Spanish National Code to market the product through Pharmacy channel.
© Trinity Solutions S.L. - C/ Rodriguez Marín, 88 - 2º B · Madrid - (+34) 91 457 48 03
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