Services for Medical Devices:
Registration of Medical Device - Preparation, review, and submission of the necessary technical dossier for the registration of Medical Devices with the local regulatory agency
Notification of Medical Device - Preparation, review, and submission of the necessary technical dossier for the notification of Medical Devices to the local regulatory agency
Good Manufacturing Practice Certification for Medical Devices
Good Distribution Practice Certification for Medical Devices
Post registration Services (Hosting Services - Local Representation for Medical Devices) - Legal Representative, Post-registration Surveillance, and Technical Representation
Importation and Exportation of Medical Devices
EUDAMED Registration
Post-Market Surveillance
Risk Classification Analysis - Determining the correct classification of medical devices according to the local regulatory agency
MDD to MDR Update for the European Union
MDR Dossier Preparation for Medical Devices
INMETRO Certification (National Institute of Metrology) - IEC 60601
ANATEL Certification (National Telecommunications Regulatory Agency)
ISO 13485 Certification
ISO 14971 Certification
CE Mark for Medical Devices
Authorized European Representative (EUAR - EU REP)
National Representation (In-Country Representation - Local Representative)
Certificate of Free Sale
Unique Device Identification (UDI)
MDSAP Certification - Medical Device Single Audit Program
MDSAP Audit
Medical Device Clinical Evaluation Report
Periodic Safety Report (PSUR)
Person Responsible for Regulatory Compliance (PRRC)
Ensuring the safety and performance of in vitro diagnostic medical devices (GSPR)
Assignment of Medical Device Regulation Codes (MDC)
Conformity Assessment - Verification of medical devices compliance with regulatory requirements, including documentation analysis, testing, and certifications
Post-Market Studies
Post-Market performance follow-up (PMPF)
Post-Market Clinical Follow-up (PMCF)
Clinical Evaluation Report (CER)
Registration Renewal
Post-Registration Changes
Renewal of Medical Device Registration
Transfer of Medical Device Registration Ownership
UK Responsible Person (UKRP) for Medical Devices
Swiss Authorized Representative (CH-REP) for Medical Devices
United Kingdom Conformity Assessment Certification (UKCA)
MHRA Support
First Instance Administrative Appeal - Medical Device Regularization
Verification and Validation of Medical Devices - Preclinical and Clinical Studies
Post-Market Monitoring
Preparation for Notified Body Audits
Compliance Audits
Regulatory-Strategic Support
Documentation Gap Analysis
Preparation of technical feasibility studies for regularization of medical devices
Labeling Requirements Verification
Handling of Complaints and Recalls
Medical Device Registration Cancellation
Preparation of Responses to Notifications and Sanitary Infractions
other services
Regulatory & Quality
ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.
Distribution Headhunting
ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.
Import
ELS Solutions provides a robust Import, Warehousing, Billing and Customer Service service, in the countries where it is represented, so that the customer controls their business, their margin and does not need to depend on the distributor, focusing on increasing of sales.
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