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International Certifications (CE Mark / FDA)
Technical documentation structured to MDR/IVDR and FDA requirements, support with Notified Bodies and submission strategy.
Lines of business
Services
Technical consulting in Regulatory Affairs and Quality Management Systems for medical devices, in vitro diagnostics, cosmetics and related products.
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Product Registration (ANVISA)
Regularization of medical devices, IVD, food, cosmetics and sanitizers: complete dossiers, responses to requirements and process follow-up.
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INMETRO Certification
Product and documentation preparation for testing in accredited laboratories and mandatory certification for medical equipment.
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Quality Management System
QMS implementation and maintenance per RDC 665 (GMP) and ISO 13485, internal audits, team training and inspection readiness.
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Specialized technical documentation
Risk management (ISO 14971), biocompatibility evaluation, clinical evaluation, usability engineering and technical reports.
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Registration Holder
Registration ownership in Brazil for foreign companies, with technical responsibility, compliance and post-registration maintenance.
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CGA Training
In-company training and a portfolio of courses on regulatory affairs, quality and national and international regulatory updates.