Certification
Medical device certification
Why is certification necessary?
Medical device certification is a mandatory procedure that confirms that a product complies with the legal requirements of a specific country or region. Without this procedure, it is impossible to legally sell, import, or use equipment in jurisdictions such as the European Union, the United States, Canada, the Middle East, and Asia.
Main types of certification:
- CE (Conformité Européenne) — for entry into the EU market;
- FDA (Food and Drug Administration) — for supplies to the United States;
- ISO 13485 — international standard for quality management in the field of medical devices.
What do we offer?
- Consulting and documentation audit
We analyze technical documentation, instructions for use, labels, and test protocols for compliance with CE, FDA, ISO, and other standards. - Preparation of a complete set of documents
We develop and adapt technical dossiers, clinical evaluations, risk analyses, and other necessary documents. - Interaction with certification bodies
We accompany the entire process from application submission to final certificate receipt, including communication with notified bodies, registration agencies, laboratories, and regulatory authorities. - Post-marketing support
We ensure compliance with post-marketing surveillance (PMS) requirements, safety reports, CAPA, and other obligations after the product is launched on the market.
- Consulting and documentation audit
Why choose us?
- Expertise in EU and US regulatory affairs
- International team of engineers and quality specialists
- Transparent pricing and clear deadlines
- Localization of packaging and instructions
