Compliance Pathway:
Manufacturer
Explore below how Smart Regulations can assist and fit around meeting your compliance needs and how we can support you on the compliance journey effectively and for the best value.
Understanding the key differences between the two pathways is shown in the table below as some organisations will have multiple roles where you may manufacture products but also distribute others or integrate smart devices into your service offerings. To find out more about the Distributor and End User pathway click here.
The Challenge
This pathway is for:
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Original Equipment Manufacturers (OEMs)
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Product Designers & Engineering Teams
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Product Managers launching IoT-enabled devices
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Software developers of “products with digital elements”
Your key challenge: Building compliant, secure devices that meet regulatory obligations for CRA, RED, and PSTI and other regulations. This includes from design to market launch, including maintaining security throughout the product lifecycle.
Compliance Needs
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Product Development Planning with Compliance Embedded
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Understand CRA essential cybersecurity requirements early
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Plan design to meet security-by-design obligations
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Align with ETSI EN 303 645 and emerging harmonised standards
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Technical Documentation & CE/UKCA Preparation
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Prepare required documentation for CE/UKCA marking
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Map technical decisions to regulatory requirements
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Develop Software Bill of Materials (SBOM), vulnerability handling processes
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Third-Party Assessment & Certification
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Navigate requirements for critical products under CRA needing external conformity assessment
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Coordinate lab testing for RED Article 3.3 cybersecurity clauses
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Post-Market Compliance
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Set up vulnerability disclosure process
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Plan for security updates and patches lifecycle management
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How We Help
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Compliance Roadmap Creation – Build a step-by-step plan integrating compliance into product lifecycle
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Design Advisory & “Security by Design” Workshops – Embed security controls at technical level aligned to CRA/ETSI EN 303 645
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Documentation Support – Templates and coaching for Technical Files, EU Declaration of Conformity
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Audit & Gap Assessment – Review your product against CRA, RED, PSTI obligations before market placement
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Certification Readiness Support – Prepare for third-party assessments where needed (e.g. CRA critical devices)
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Team Training – Equip engineering, legal, and product teams to sustain compliance internally
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Product Testing - Ensure your products have gone through robust assurance testing for compliance to meet the CRA and RED
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Contact us below to start the discussion...
