services
Medical devices
As a consultancy specialising in technical and legal procedures for the biopharmaceutical and medical devices industry, we advise you on and handle all procedures relating to medical devices in general and in vitro diagnostic devices.
Authorisation of manufacturing/importing companies’ premises
Companies engaged in any of the following activities – the manufacture, import, assembly and/or sterilisation of medical devices – must hold authorisation for their premises, granted by the Sub-Directorate-General for Medical Devices of the AEMPS
Marketing communications
We carry out the necessary procedures for the registration and marketing of PS (marketing notifications)
Registration of distribution companies
Companies that distribute medical devices must submit a notification or apply for authorisation (depending on the Autonomous Community) to the health authorities of the Autonomous Community in which the company is based.
Health Authority Approval for Advertising
At the Pharmaceutical Technical Office, we advise you and meet your needs regarding the preparation and submission of applications for the advertising of medical devices to the general public to the relevant health authorities.
Technical Dossier for the Medical Device
Preparation of the Technical Dossier or Technical Documentation for medical devices, in accordance with the new Regulation (EU) 2017/745, covering both Class I devices subject to self-certification and those requiring CE marking by a Notified Body.
Contact us, without any obligation.
Cosmetic products
Medical devices
Parapharmacy codes
Food supplements
Biocides and disinfectants
Bio-sanitary training
Health establishments
Implementation of quality systems
