ILAC & ANVISA Lab Coordination

Testing Strategy & Laboratory Coordination

Testing should be planned from the regulatory decision backward. NKB Regovanta helps manufacturers identify what evidence is needed for Brazil, whether existing global reports can be leveraged, and where new studies are required. Where third-party testing is needed, we can coordinate with established laboratories and review protocols and reports before they enter the ANVISA dossier.

Build Your Brazil Testing Strategy

When This Support Is Needed

Existing global test reports do not fully cover the Brazilian marketed device configuration

ANVISA has raised a specific testing or pre-clinical validation exigência during technical review

A new device family or complex grouping requires scientifically justified worst-case model selection

IVD analytical or clinical performance evaluation studies are required under RDC 830/2023

A design, raw material, manufacturing site, or sterilization change creates new testing requirements

What We Challenge Before Submission

Does the study protocol test the actual commercial device or an appropriate, justified worst case?

Are acceptance criteria linked directly to design inputs, risk controls, or clinical relevance?

Does the final lab report identify models, lot numbers, software versions, and configurations clearly?

Can the test evidence bridge minor engineering differences between global and Brazilian variants?

Will ANVISA assessors be able to cleanly trace the test outcome to the claimed clinical performance?

Testing Areas We Support & Coordinate

Testing gap assessment against Brazilian and international recognized standards

Applicable standard and test method review (ISO, IEC, ASTM, CLSI, Pharmacopoeia)

Worst-case device and configuration rationale documentation

Sample-size, lot selection, and statistical power rationale development

Protocol and acceptance-criteria review prior to study initiation

Laboratory coordination with ANVISA-recognized and ILAC/RBC-accredited facilities

Biocompatibility and chemical characterization testing (ISO 10993)

Sterilization validation, packaging seal integrity, and shelf-life ageing studies

Electrical safety and EMC testing (IEC 60601 series & INMETRO certification interface)

Bench, mechanical, durability, and functional performance testing

Software verification and validation (IEC 62304)

Cybersecurity penetration and vulnerability assessment evidence

Human factors and usability engineering testing (IEC 62366-1)

IVD analytical and clinical performance studies

Final laboratory report regulatory adequacy review before dossier insertion

Regulatory Testing Philosophy:

We do not simply send a test list to a laboratory. We define the regulatory question the study must answer, challenge the configuration and acceptance criteria, and make sure the resulting report can be used directly in the Brazilian technical dossier.

Design and Coordinate Your Pre-Clinical Testing for ANVISA Approval

Our team structures test plans, justifies worst-case articles, and manages accredited testing laboratories.

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