04 / PRODUCT ASSURANCE & COMPLIANCE
Build compliance into the product. Not around it.
We help technology companies manage product risk, verification, validation and regulatory compliance from development through market release.
From DFMEA and compliance planning to CE, UL, testing, certification and technical documentation.
Compliance shouldn't be discovered at the end of development.
Product requirements, technical risks and regulatory requirements are often managed separately. The consequences appear late: missing tests, incomplete evidence, design changes that trigger revalidation or certification issues just before market release.
We connect product risk, requirements, verification, testing and compliance so that evidence is built as the product develops.
This makes compliance part of product engineering rather than a final documentation exercise.
Earlier risk visibility. Clearer evidence. Fewer late surprises. More predictable market release.
Product Assurance & Compliance
Product Risk & Assurance
DFMEA · Product risk · Requirements · Verification · Validation
Product risks and critical requirements translated into appropriate verification, validation and evidence.
CE & EU Compliance
CE marking · EU Directives & Regulations · Harmonised Standards
Applicable requirements, conformity assessment, testing strategy, technical documentation and Declaration of Conformity.
UL & Market Access
UL requirements · Testing · Certification coordination
Identification of applicable requirements, preparation for testing and certification, technical evidence and coordination through the approval process.
Technical Compliance
EMC · Electrical safety · RED · RoHS · REACH · Product safety
Applicable technical and regulatory requirements identified and integrated into product development and validation.
WHAT WE BUILD OR IMPROVE
Product assurance strategy
A structured approach connecting requirements, product risks, verification, validation, compliance and release.
DFMEA & product risk management
Identification and control of technical and safety risks throughout product development.
Verification & validation planning
Requirements translated into test, inspection, analysis and other objective evidence.
Compliance & certification planning
Applicable regulations, standards, certification routes, test requirements and evidence identified early.
Technical documentation
Structured compliance evidence, test documentation, declarations, risk assessments and technical-file readiness.
Change-impact assessment
Product, component, supplier and manufacturing changes assessed for their impact on risk, testing, compliance and certification.
When this service makes sense
01 . You're preparing a product for market release.
Applicable requirements, testing, certification and technical evidence need to be established before launch.
02. You need CE, UL or other product approvals.
Critical suppliers are affecting quality, delivery or production, or their capability for future volumes hasn't been demonstrated.
03. Product changes are creating compliance questions.
Components, suppliers, software, design or manufacturing processes are changing and the impact on testing or certification needs to be understood.
04. Verification and compliance are happening too late.
Testing, technical documentation and certification activities are concentrated near release, creating delays, rework and unexpected costs.
Preparing a product for testing, certification or market release?
Let's establish what applies, what evidence you already have and what still needs to be demonstrated before release.