Services for Medical Devices:
Risk Analysis - Determine the correct classification of medical devices according to local regulatory body
Preparation and review of the technical dossier required for registration of Medical Devices with local regulatory body
Registration Renewal
Post-registration changes
Training and Education
Compliance Audits
Import and Export Advice
Conformity Assessment
Document Management
Equivalence Assessment
Regulatory-strategic support
Clarifying Technical doubts
Gap analysis
Preparation of feasibility reports
Regulatory Impact Assessment
Good Manufacturing Practice (GMP) Compliance Assessment
Analysis of Clinical Studies
Verification of Labeling Requirements
Evaluation of Registration Documents obtained in other countries
EU MDR Transitions
Advice on Testing and Certification
Assistance in obtaining Local Regulatory Body Certification
Assistance in obtaining INMETRO Certification in Brazil
Assistance in obtaining ISO 13485 Certification
Support in preparing for Regulatory Inspections
Review of regulatory documents
Assessment of Quality Control and Manufacturing Requirements
Assistance in obtaining CE Certification
Advice on Complaints and Recalls
Post Market Clinical Follow-up
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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