English (UK)
中文版AdviQual End. Dan. San. Tic. Ltd. Şti. 
RA/QA and clinical services consultancy company dedicated to medical devices.
We have been providing services to a wide variety of medical devices in every Class to prepare technical documents for CE certification and FDA authorization.
Services that are sought most are
Compiling or updating Technical Files according to MDR (EU 2017/745) and IVDR (EU 2017/746)
CEP, CER, PMCF Plan, Clinical Trial Protocols
QMS updates
Sterilization Validation, Process Validation, Packaging Validation, Software Validation, etc.
GAP, Mock, Supplier Audits
Medical device registration in 140 countries
We have been providing services to a wide variety of medical devices in every Class to prepare technical documents for CE certification and FDA authorization.
Services that are sought most are
Compiling or updating Technical Files according to MDR (EU 2017/745) and IVDR (EU 2017/746)
CEP, CER, PMCF Plan, Clinical Trial Protocols
QMS updates
Sterilization Validation, Process Validation, Packaging Validation, Software Validation, etc.
GAP, Mock, Supplier Audits
Medical device registration in 140 countries
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