SERVICES
SERVICES
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Technical and Regulatory-Industrial Auditing
Technical and Regulatory-Industrial Auditing
✔ Technical compliance audits for products
✔ Regulatory audits to meet INMETRO requirements
✔ Industrial process audits from a regulatory perspective
✔ Pre-certification audits (gap analysis / readiness assessment)
Product Certification Consulting – INMETRO 148 and 384
Product Certification Consulting – INMETRO 148 and 384
✔ Regulatory feasibility assessment
✔ Definition of product certification strategy
✔ Preparation and review of technical files
✔ Technical support with Certification Bodies and testing laboratories
✔ Follow-up of testing and audit activities
Standards Compliance Assessment (IEC | ISO | ABNT)
Standards Compliance Assessment (IEC | ISO | ABNT)
✔ Technical interpretation of applicable standards by product type
✔ Standards gap analysis (ABNT vs IEC)
✔ Technical and regulatory risk assessment
✔ Support for product and design compliance
Regulatory Product Classification
Regulatory Product Classification
✔ Regulatory framework and classification analysis
✔ Assessment of products as:
Medical devices
Non-regulated products
Products subject to mandatory certification
✔ Issuance of technical opinions and reports
Industrial Process Auditing and Improvement
Industrial Process Auditing and Improvement
✔ Industrial process audits
✔ Failure and nonconformity analysis
✔ Support in adapting manufacturing processes to regulatory requirements
✔ Integration of quality, engineering, and certification activities
Preparation for INMETRO / CB Audits
Preparation for INMETRO / CB Audits
✔ Pre-audit diagnostics
✔ Mock audits and audit simulations
✔ Nonconformity correction support
✔ Training and preparation of internal teams
Regulatory Impact Analysis
Regulatory Impact Analysis
✔ Impact assessment of new ordinances, amendments, and normative instructions
✔ Risk analysis related to product discontinuity or market restrictions
✔ Regulatory adaptation and transition planning
Import and Market Access Technical Support
Import and Market Access Technical Support
✔ Regulatory assessment prior to importation
✔ Technical documentation review from foreign manufacturers
✔ Documentation adaptation for the Brazilian market
Questions?
e-mail: kpisbrasilconsultoria@gmail.com fone: +55 11 963242877
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