1. Two Regulatory Models, One Engineering Approach for Reliable AMR Compliance

Global product compliance follows two distinct models:

Europe & United Kingdom (Ex-Ante Conformity)

• Centralized regulatory framework
• Mandatory conformity assessment before market entry
• CE and UKCA marking based on documented compliance

United States (Standards & Workplace-Based)

• No single government-issued certification
• AMR Compliance achieved through federal regulations, consensus standards, and workplace safety requirements
• Acceptance driven by customers, insurers, and authorities having jurisdiction (AHJs)

Despite these differences, Model C2 is engineered to satisfy both models simultaneously.

2. CE & UKCA Certification (European Union & United Kingdom)

Model C2 AMR compliance includes achieved CE and UKCA certification, enabling commercial deployment across the European Union and the United Kingdom.

Certification Scope

CE and UKCA certification was completed following a six-month, end-to-end conformity assessment program, conducted with independent engineering consultancies and third-party testing organizations.

The process included:

• Formal risk assessment and hazard mitigation
• Functional safety validation for autonomous mobile robots
• Electrical, EMC, radio, and battery safety testing
• Software and failsafe behavior validation
• Creation of compliance and traceability matrices
• Compilation of objective evidence and technical documentation

Model C2 is CE and UKCA marked in accordance with applicable regulations.

3. EU & UK Regulatory Framework

Model C2 conforms to the following primary regulatory instruments:

• Machinery Regulation (EU) 2023/1230
• Electromagnetic Compatibility Directive (2014/30/EU)
• Radio Equipment Directive (2014/53/EU)
• EU Battery Regulation (EU) 2023/1542
• General Product Safety Regulation (EU) 2023/988

Applied Harmonized Standards (Selection)

Machinery & Functional Safety – EN ISO 12100 – Risk Assessment & Risk Reduction – ISO 3691-4 – Driverless Industrial Trucks (AMRs) – EN ISO 13849-1 – Safety-Related Control Systems – EN ISO 13850 – Emergency Stop – EN 60204-1 – Electrical Equipment of Machines

EMC & Radio – EN 61000-6-1 / -6-3, EN 61000-4 series – EN 55032 / EN 55035 – EN 300 328, EN 301 893, EN 301 489 series – EN 62311 – RF Exposure

Battery Safety – IEC 62133-2 – Lithium-Ion Battery Safety – UN 38.3 – Battery Transport

4. United States Compliance Framework

There is no CE-style certification in the United States. Instead, compliance is achieved through federal regulations, industry consensus standards, and workplace safety compatibility.

Model C2 is designed to meet these U.S. requirements.

5. U.S. Federal & Mandatory Requirements

FCC – Electromagnetic Compatibility & Radio

Model C2 complies with Federal Communications Commission (FCC) Part 15 requirements:

• FCC Part 15, Subpart B – Unintentional radiators
• FCC Part 15, Subpart C / E – Intentional radiators (Wi‑Fi / Bluetooth)

These requirements are mandatory for legal sale and operation of electronic and wireless devices in the United States.

Battery Transport

• UN 38.3 compliance for lithium-ion battery transport
• Alignment with DOT, IATA, and IMDG transport requirements

6. U.S. Safety & Consensus Standards Alignment

Autonomous Mobile Robot Safety

Model C2 is designed and validated in alignment with key U.S. consensus standards, including:

• ANSI/RIA R15.08 – Safety Requirements for Autonomous Mobile Robots
• ANSI B56.5 – Driverless Industrial Vehicles
• ANSI Z535 – Safety Signs, Labels, and Instructions

These standards address safe operation in shared human environments, including emergency stop behavior, speed and proximity control, obstacle detection, stability, and clear user warnings.

Electrical & Industrial Safety

Model C2’s electrical design aligns with commonly expected U.S. standards:

• UL 62368-1 – Product Electrical Safety (design alignment)
• NFPA 79 – Electrical Standard for Industrial Machinery

Third-party evaluation by an OSHA-recognized Nationally Recognized Testing Laboratory (NRTL) may be provided where required by customers or facilities.

7. OSHA Workplace Compatibility (United States)

The Occupational Safety and Health Administration (OSHA) does not certify products. Instead, it regulates employer responsibility for workplace safety.

Model C2 supports OSHA compliance by:

• Aligning with recognized ANSI, RIA, and NFPA standards
• Supporting employer risk assessments and job safety analyses
• Providing predictable, deterministic behavior suitable for shared workspaces

In the event of a workplace review or investigation, OSHA references conformity to these consensus standards.

8. Software, Cybersecurity & Data Protection

Model C2 is designed with security and privacy as core principles across all regions:

• No collection or storage of personally identifiable information (PII)
• No audio recording or media storage
• Vision systems used solely for localization, without image retention
• Secure access control and authenticated interfaces

Cybersecurity practices are aligned with: – ETSI EN 303 645 (EU baseline) – NIST Cybersecurity Framework principles (U.S.)

9. Validation, Traceability & Documentation

Across all regions, Model C2 compliance is supported by:

• Structured test plans covering safety, performance, environment, and software
• Formal risk assessments and hazard analyses
• Compliance and traceability matrices mapping requirements to evidence
• Objective evidence including logs, measurements, photos, and reports

This approach ensures predictable, verifiable behavior, which is particularly important for regulated and safety-conscious industries.

10. Documentation Availability

Quasi Robotics maintains comprehensive technical documentation, including:

• EU & UK Declaration of Conformity
• CE/UKCA Technical File
• Test plans and validation reports
• Safety and user documentation
• FCC and battery transport statements

Documentation is available to customers, partners, insurers, and regulatory authorities upon request.

📄 Request compliance documentation: support@quasi.ai

11. One Platform, Global AMR Compliance Readiness

Model C2 was engineered from the outset for global deployment:

• Designed to meet CE, UKCA, and U.S. expectations
• Validated through rigorous testing and documentation
• Safe for shared human environments
• Supported by a mature compliance and quality process

This unified approach allows customers to deploy Model C2 with confidence—across regions, industries, and regulatory environments.

Quasi Robotics
321 Ballenger Center Dr.
Frederick, MD 21703 USA
🌐 www.quasi.ai
📧 info@quasi.ai