Technical and Legislative Consultancy for EU Compliance
In this way, we accelerate market access and strengthen product positioning through compliance and reliability.
About Us
Experts in CE Marking and European Compliance
Mission
We make market access simple, fast, and secure.
We facilitate the free movement of goods across Europe by transforming regulatory complexity into practical, actionable steps. We map applicable directives and regulations, define adaptation plans, prepare and verify technical documentation and EU Declarations of Conformity, conduct audits and factory inspections (also in Asia), and complete the CE marking process up to sales readiness. Our goal is to reduce non-compliance risks, shorten time-to-market, and strengthen the competitiveness of your products through a clear, transparent, and measurable approach along the entire value chain.
Our History
From Regulatory Consultancy in Europe to Operational Management in China
Our story began with laboratory experience (EMC and LVD) and evolved into field operations: integrating consultancy, documentation, and production inspections to reduce risk and market entry times.
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2006 – The Origins
SQM was founded to provide specialized consultancy on regulatory compliance.
Its founder, Pietro Piras, brings extensive experience gained in EMC and LVD laboratories. -
2014 – Presence in China
Opening of the Shenzhen office to operate before import: manufacturer selection, supervision of the production process, in-production inspections, verification, and corrective actions to ensure compliance.
What We Do
End-to-End Services for Market Access
We assist companies from regulatory analysis to implementation: translating EU requirements into concrete actions, verifying documentation, monitoring suppliers and production in Asia, and supporting go-to-market operations with full control over timing and quality.
EU and International Conformity
We analyze applicable directives, regulations, and standards, identify gaps and risks, and define the adaptation path. We create a roadmap with clear priorities, responsibilities, and timelines to achieve compliance and maintain ongoing control.
CE Marking
We manage the entire process: conformity assessment, preparation of Technical Documentation, labeling, user instructions, and EU Declaration of Conformity. We coordinate testing and verification activities.
Quality & Process
We design and optimize practices and quality systems that meet regulatory requirements and enable continuous improvement. We standardize controls, records, and responsibilities to reduce non-conformities, returns, and operational costs.
Pre-Import (China/Asia)
We select and qualify suppliers, supervise production, conduct inspections (pre-production, during production, pre-shipment), and verify product compliance. We activate corrective actions promptly to prevent issues before shipment.
Go-to-market
We coordinate all final activities for market placement: document alignment, traceability, and inspection readiness. We support both technical and commercial teams to meet deadlines and fulfill authority and audit requirements while optimizing time-to-market.
Why Choose SQM
Compliance without surprises: expertise, efficiency, and a strong Europe–China presence.
We combine in-depth knowledge of directives and regulations with an operational method that reduces non-compliance risks and accelerates time-to-market. With a presence in both Europe and China, we turn regulatory requirements into compliant, competitive products that strengthen your brand’s reputation and market positioning.
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EU Regulatory Expertise
We interpret directives, regulations, and implementation guides, mapping applicable requirements and translating them into operational actions (evaluations, technical dossiers, labeling, declarations), ensuring complete regulatory compliance.
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Operational Efficiency
We define a roadmap with priorities and timelines, streamline procedures, and prevent non-conformities: fewer delays and reworks, faster time-to-market, and lower costs under full control. -
Europe–China Presence
A single management system connecting regulatory consultancy in the EU with factory oversight in Asia: supplier selection and qualification.
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Value for the Brand
Compliant products and solid documentation strengthen the trust of clients and authorities, reduce the risk of sanctions or recalls, and enhance reputation and competitiveness in the long term.
How We Work
From Requirements to Market Launch: Our 4-Step Method
We apply a clear and measurable process that reduces risks, time, and rework.
From the initial CE marking assessment to readiness for sale, we define responsibilities, deliverables, and milestones — coordinating tests, documentation, and factory checks to ensure solid and sustainable compliance.
1. Assessment
We analyze the product, its intended use, and destination markets; we map applicable directives, regulations, and standards and identify technical and documentary gaps.
We assess risks, priorities, and cost/time impacts, verify existing documentation (drawings, BOMs, manuals, etc.), and set up the compliance matrix that will guide all subsequent phases.
2. Action Plan
We build an operational roadmap with activities, deadlines, and acceptance criteria. We plan testing and verification (laboratories, notified bodies), prepare templates and checklists for Technical Documentation and the Declaration of Conformity, define decision-making and reporting cadence, and align with suppliers and internal departments (R&D, quality, logistics).
3. Execution & Verification
We draft and collect documents (technical file, manuals, labels), coordinate testing and inspections, carry out factory audits (pre-production, during production, pre-shipment), and verify batch compliance.
We activate corrective and preventive actions (CAPA), manage compliance updates, ensure traceability, and monitor changes until all non-conformities are closed.
4. Conformity & Release
We finalize CE marking, EU Declaration of Conformity, and labeling/instructions in the language of the destination country. We deliver the complete documentation file, align the team on post-market surveillance requirements, and define documentation retention and update procedures.
The product is ready for market placement, meeting deadlines and regulatory requirements, and is well prepared for audits and authority inspections.