| Facilities
ZURKO RESEARCH
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.
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- 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.)
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- 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.
