Approval of a medical device

The process of obtaining approval for a medical device from the Spanish Medicines Agency involves:

• Product classification, clinical evaluation, laboratory testing, and the technical file. We are the consultancy firm that can help you classify your medical device to obtain its CE marking. Please get in touch with us.
• Prior operating or manufacturing licence for medical devices. This licence is a mandatory requirement to begin marketing any medical device within the European Union.
• A prior import licence for medical devices is a mandatory requirement to begin marketing any medical device within the European Union. This is a procedure that must be approved by the AEMPS, whether you are a manufacturer or importer of medical devices.
• Registration of a technical guarantor with the AEMPS. The Technical Manager is a necessary role for obtaining the Operating Licence granted by the AEMPS. This is required as part of the CE marking process for medical devices.
• Technical documentation for the CE marking of medical devices. We help you draft the technical documentation containing information on the design, manufacture and operation of a product. It includes all the data required to demonstrate that the product complies with the requirements.
• Implementation of a Quality Management System in accordance with ISO 13485. We streamline the project using our ‘paperless’ methodology based on Microsoft 365. Thanks to this implementation, you will easily achieve ISO 13485 certification.
• Test management and verification with a Notified Body for CE marking. We help you coordinate the necessary tests to comply with the applicable legal requirements.

We can assist and advise you throughout the entire procedure for the approval of any type of medical device.