INMETRO Certification: compliant medical electrical equipment.

We manage the INMETRO conformity certification required for medical electrical equipment and various devices, from identifying the applicable ordinance to IEC 60601 series testing and management of the process with the product certification body (OCP).

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INMETRO Certification: compliant medical electrical equipment.
What we deliver

We guide your product through the entire mandatory certification process.

  1. Assessment of the product against applicable INMETRO ordinances.

  2. Gap analysis against the IEC 60601 series and particular standards.

  3. Preparation of technical documentation and test samples.

  4. Liaison with accredited laboratories and the product certification body (OCP).

  5. Management of test nonconformities and certification maintenance.

Deliverables

What you receive

A regulatory assessment report and certification plan.
A standards gap analysis (IEC 60601 and related standards).
A technical dossier and support throughout testing.
Follow-up through to certificate issue and INMETRO registration.
References

Reference standards

  • INMETRO ordinances applicable to medical electrical equipment.
  • IEC 60601 series (basic safety and essential performance) and particular standards.
  • Accredited OCP requirements and integration with ANVISA registration.
FAQ

Frequently asked questions

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Does your medical electrical equipment already have INMETRO certification?

We manage the process from initial assessment to certification.

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