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.
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