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.