Facilities Licensing

Processing, maintaining, amending, extending and updating existing operating licenses for medical device facilities

Advice on medical device facility license applications in accordance with RD 1591/2009 and circular 22/99 and AEMPS (Spanish Agency of Medicines and Medical Devices) application procedures.

      • Checking documentation required for the medical device manufacturer’s license application (documentation regarding facilities, organization, in-house work procedures and those of subcontracted companies with regards to manufacturing, storage, marketing, etc.)
    • Providing formal documentation models.
    • Reviewing contracts and procedures for supplier, subcontractor and control laboratory interactions.
    • Managing the AEMPS portal to comply with manufacturing facility requirements.