Technical Compliance and Certification

We support companies in the development, verification, and certification of electrical, electronic, and mechatronic equipment.

What we do

Compolab supports companies and manufacturers in defining the most appropriate certification pathway for electrical and electronic products intended for use in both industrial and residential environments, across various application fields: Radio Frequency (RF), Mechatronics, Medical, and Home Appliances.

We operate with a comprehensive approach that integrates regulatory analysis, technical assessments, pre-compliance testing, and preparation of the required documentation for compliance with key European directives and regulations (EMC, LVD, RED, MID, Machinery, MDR).

A distinctive element of our methodology is the ability to intervene already at the design stage, suggesting architectural, technical, and component-level choices that meet regulatory requirements. This helps reduce time, costs, and the risk of non-compliance in the final stages of the project.

We carry out preliminary assessments, identify potential critical issues, and support companies and manufacturers throughout all stages required to obtain CE marking or certifications needed for non-EU markets.

Our goal is to ensure safe, compliant products that are ready for market launch, following a clear, structured, and reliable certification process.

How we work

Our approach integrates regulatory analysis, engineering expertise, and testing activities to support companies and manufacturers throughout every stage of the certification process.

How We Intervene - COMPOLAB
01

Regulatory definition and analysis

Customized certification scenarios based on commercial needs.

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We evaluate the involved directives, regulations and applicable technical standards, defining, according to the manufacturer's commercial needs, different certification path scenarios (CE, UL/FCC, CSA, CB Scheme Test Certificate CBTC, etc.) and the mandatory requirement of a Notified Body (NB).

02

Preliminary technical analysis

Evaluation of architectures, components and Risk Assessment.

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We evaluate architectures, diagrams, layouts, electrical/electronic/mechanical components, and risk (Risk Assessment). We provide preventive guidance to ensure 'certification-ready' design.

03

Pre-compliance testing

Preventive checks to anticipate anomalies and non-conformities.

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We carry out internal checks or at partner labs to anticipate anomalies and reduce the risk of non-compliance.

04

Documentation support and Technical File

Complete preparation of technical file, risk analysis and manuals.

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We draft or support the preparation of the technical file, risk analyses, manuals.

05

Management of relations with Notified Bodies (NB) and accredited laboratories

Coordination of audits and tests with international accredited bodies.

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We coordinate audits, official tests and verifications with accredited bodies (NEMKO, TÜV, IMQ, INTERTEK, RINA, DEKRA, KIWA, etc.).

06

Non-conformity management

Design solutions to overcome identified issues.

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We analyze test results and propose design solutions to overcome criticalities.

07

Final validation and conformity release

Full support until the certification process closure.

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We support the client in final tests and closure of the certification process.

Our Strategic Expertise

The combination of engineering, regulatory, and testing competencies is what enables us to transform complex requirements into robust and reliable certification pathways.

Our Expertise - COMPOLAB

Compliance-Oriented
Design
(Design for Compliance)

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Main activities

  • Guidelines for electrical and electronic architectures
  • Assessment of electrical safety and EMC requirements applied to: PCB layout and assembly and/or electrical panels, critical components
  • Prevention of main non-conformity causes in EMC and electrical safety
  • Selection and use of components according to their product standards and manufacturer specifications
  • Definition of "certification-ready" design solutions
  • Risk assessment using standardized methodologies (FMEA, FTA, etc.) to identify, evaluate and reduce risk. Main reference standards: EN ISO 12100, IEC 60601

Testing and
pre-compliance

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Main activities

  • Internal EMC tests and tests at partner laboratories
  • Electrical safety tests according to main technical standards
  • Dimensional, functional and safety checks
  • Identification of critical issues and definition of corrective technical actions

Technical Compliance
Documentation

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Main activities

  • Technical File
  • User and maintenance manuals
  • Installation manuals
  • Declarations of conformity
  • Risk analysis
  • Regulatory checklists and document audits

International
Certifications

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Main activities

  • CE (Europe)
  • UL / FCC (United States)
  • CSA (Canada)
  • CB Scheme Test Report

Key Directives
of Competence

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Main activities

  • EMC (2014/30/EU)
  • LVD (2014/35/EU)
  • RED (2014/53/EU)
  • MID (2014/32/EU)
  • Machinery Directive (2006/42/EC) (Note: valid until 2027, the new directive 2023/1230/EU becomes mandatory)
  • Medical Device Regulation (MDR 2017/745)
Real Experiences - COMPOLAB

From Design to Certification

Concrete examples from our portfolio: real projects in which we supported companies and manufacturers throughout the entire certification path, from design to compliance release.

Gi.Metal

I-REDBOX

Oven Food Delivery

CE certification for a device with cellular and GPS transmission modules. Full support through regulatory analysis, test coordination and management of the conformity process.

RED EMC LVD
DIRAC

ALBERO HOME

Air purifier for indoor environments

Device with Bluetooth and Wi-Fi modules intended for indoor environments. Management of the CE certification path with support for verification activities and technical compliance.

RED EMC LVD
INAIL

Prosthetic Arm

Medical device

Medical device with stringent safety and conformity requirements. Support for CE certification in collaboration with an accredited medical laboratory.

MDR EMC LVD
StickerMule

Label Dispenser

Label dispenser for EU / USA / Canada markets

Device intended for multiple international markets. Management of CE certification (CB Scheme – NEMKO) and UL/CSA certifications for North American markets.

CE UL/CSA CB Scheme NEMKO
Compolab

Battery Rack Test Bench

Industrial test system

High-power industrial test system. CE certification through the application of EMC and LVD directives, with technical verification and conformity to applicable standards.

CE EMC LVD
System of Competences - COMPOLAB

A system of competences

An integrated ecosystem. Five technical departments, a shared method and the ability to orchestrate diverse
know-how into coherent solutions. This is the value we provide to our clients.