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Home
About Us
Our Services
Regulatory Approvals
Europe
CE Marking for Medical devices
CE Marking For In-Vitro Diagnostic Devices
CE Marking For Software As Medical Device (SaMD)
CE Marking For Personal Protective Equipment (PPE)
CE Marking For System And Procedure Pack
CE For Drug-Device Combination (Article 117)
CE marking for Annex-XVI products
USA
USFDA 510(k)
USFDA 510k for Medical devices
USFDA 510k for In-Vitro Diagnostic Devices
USFDA 510k for Active Devices
USFDA 510k for Software as Medical Devices (SaMD)
FDA third-party review
USFDA Registration & Listing
US agent services
MDSAP
21 CFR Part 820
NIOSH
USFDA Labels
UK
UKCA marking for Medical devices
UKCA marking for In-Vitro Diagnostic devices
UKCA marking for Software as Medical Device (SaMD)
MHRA registration
UK Responsible Person (UKRP)
India
Import license
Free Sales Certificate (FSC)
Device Master File
Manufacturing License
Clinical Trials
Prospective Trials
Retrospective Trials
PMCF
PMS
Representation Services
European Authorised Representative (ECREP)
US Agent Services
UK Responsible Person (UKRP)
Swizz Representative
License Holding in multiple countries
Quality Management
ISO 13485
Preparation and Implementation of QMS
Gap analysis of QMS
MD-QMS as per EU MDR and IVDR
Internal Quality Audit (IQA) & Management Review Meeting (MRM)
Validations
Design and Development File
Certification and Audit Support
21 CFR part 820
MDSAP
Integrated Quality Management System
Country Registration
Registration documentation & application
License Holding in multiple countries
Audit Management
Internal Quality Audit (IQA)
Mock Audits
Audit NC Closer
Support with any external audit
Related Regulatory Services
UDI
EUDAMED
FSC
Liability
Gap Analysis
CER Writing
Risk Analysis
Outsource your QA/RA
Blog
Contact
Uncategozied
September 21, 2021
Ліцензійні казино в Україні