Study and regulatory expertise
Full support for compliance and approval for your export markets
Why use an EU and/or international regulatory study?
Support from our regulatory engineering department
- Identify the regulatory requirements applicable to the target markets (European Union, North America, etc.).
- Optimise approval processes.
- Ensure compliance with local and international requirements (CE marking, Schéma OC / IECEE CB Scheme, country-specific certifications).
- Define and plan the necessary tests (EMC tests, electrical safety tests, environmental tests, etc.) to guarantee equipment safety and compliance.
- Support document management to ensure smooth marketing in line with regulatory expectations.
- Implement continuous regulatory monitoring to maintain compliance throughout the product life cycle.
Our regulatory expertise covers a wide range of sectors
Our engineering services
- Regulatory compliance studies by product and by market.
- Optimisation of approval procedures from a cost and time perspective.
- Validation of technical files and certifications.
- Assistance with drafting aspects: QTP, test procedures, EU DoC, etc
- Regulatory monitoring and anticipation of changes in standards.
Regulatory support methodology
- Study and identification of regulatory requirements Administrative requirements
- Administrative requirements
- Regulatory body
- Regulatory procedures and description of approval procedures (CE, FCC, UL, etc.).
- Documents and number of samples required
- Processing & validity period
- Local representation / Local testing
- Information to appear in Notices/Marking
- Mutual Recognition Agreements (MRAs)
- Technical requirements
- Applicable national standards / Possible equivalences
- Conditions of use of the radio frequency spectrum; Validity/application of the concept of module (Modular Approval)
- Connections / Mains voltage
- Administrative requirements
- Technical validation and regulatory tests
- Determination of tests required to ensure compliance (EMC, electrical safety, environmental, etc.).
- Proposal to carry out reliability tests (HALT - Highly Accelerated Life Testing_, HASS - Highly Accelerated Stress Screening_), durability tests or functional validation tests.
- Document management and certification
- Assistance in compiling technical files (EU DoC, user manuals, etc.).
- Validation of user manuals, notices and regulatory markings.
- Support for audits and inspections by certification bodies.
- Ongoing monitoring and compliance
- Monitoring changes in standards by sector and by country.
- Anticipation of regulatory updates likely to have an impact on the regulatory compliance of your products.
- Support in managing the regulatory lifecycle: design modifications, standards updates, possible re-certifications.
Regulatory studies and audits
- Regulatory assessment audit: identification of gaps and development of action plans.
- Certification process diagnostics: support in obtaining accreditation.
- Support in understanding standards and reference systems (ISO, IEC, etc.).
- Technical assistance on equipment and test methodologies (EMC, environmental, reliability, etc.).
Talk to our regulatory engineering experts
Standards and regulations covered
- CE marking and European directives (EMC, Low Voltage, RED, Machinery, ATEX...) or European regulations (DM, DM-DIV...).
- OC Scheme / IECEE CB Scheme: mutual recognition of electrical engineering tests.
- International standards (ISO, IEC, FCC, UL, etc.).
- Country-specific requirements to ensure optimum access to global markets.
Why choose our expertise in regulatory studies?
- Multi-sector expertise: in-depth knowledge of multiple industries.
- Mastery of international certifications and approvals: rapid, simplified access to target markets.
- Reduced lead times and costs thanks to optimised approval procedures.
- Turnkey service: from regulatory monitoring to final certification.
- Technical and regulatory support throughout the product life cycle.
Needs
Discover a selection of additional resources that explore topics related to this page including regulatory contexts, technical articles, and specific areas of expertise. These materials provide further insight to help you better understand the key challenges and available solutions.
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