IoMT

Technical documentation and compliance certificates for Directive 2014/53/EU with radio equipment and EU flag in the background, symbolizing regulatory compliance.

Key Elements of Technical Documentation Under Directive 2014/53/EU (Annex V)

As the regulatory landscape for radio equipment in the European Union evolves, manufacturers must comply with Directive 2014/53/EU. A key part of this compliance is preparing technical documentation to prove the product meets essential requirements. Annex V outlines the key elements manufacturers must include: This documentation must be prepared before market entry and kept for …

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Visual representation of EU product compliance showing IoT devices, legal elements like a gavel, and compliance icons to illustrate market surveillance and regulatory requirements under EU Regulation 2019/1020 and the Product Liability Directive.

Avoid Market Surveillance Pitfalls: Ensure EU Product Compliance

Ensuring EU product compliance is vital for any company wanting to access the European market. With EU Regulation 2019/1020, economic operators must meet strict regulatory requirements to avoid market surveillance risks, such as fines, product recalls, and even market bans. Why Product Compliance Matters Compliance with EU regulations ensures that your products are safe, reliable, …

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Canadian and U.S. flags side by side representing the certification paths for FCC and ISED compliance for wireless devices in the U.S. and Canada.

Navigating FCC and ISED Certification: Key Differences, MRAs, and Testing Requirements

Bringing a wireless or RF device to both U.S. and Canadian markets requires a thorough understanding of FCC and ISED certification processes. Each has its unique standards, testing procedures, and compliance requirements, making it vital for manufacturers to plan their approach carefully. Key Differences Between FCC and ISED Certifications Certification Process ISED Certification: In Canada, …

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Map of mainland China excluding Taiwan with a certification symbol, representing SRRC certification compliance for radio and IoT devices. Focuses on meeting China's regulatory requirements for wireless equipment.

SRRC Certification for Radio Equipment: A Simple Guide for Manufacturers

If you’re planning to sell wireless or IoT devices in China, you’ll need SRRC (State Radio Regulation of China) certification. This is a mandatory process for any product that uses radio frequencies in China. Without it, your product can’t be sold or used legally in the country. This guide will walk you through the SRRC …

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American flag alongside the FCC logo, representing the regulatory authority of the Federal Communications Commission (FCC) over IoT devices and electronic products entering the U.S. market.

Ensuring U.S. Market Entry: FCC Compliance for Electronic Devices

If you’re planning to sell electronic devices in the United States, gaining FCC compliance is a critical step to ensure that your products can legally enter the market. Whether you’re manufacturing consumer electronics, IoT devices, or industrial equipment, adhering to FCC regulations is essential to prevent harmful interference with other devices and to protect the …

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Illustration of IoT devices complying with the UK's new Product Security Regime for enhanced protection.

UK’s New Product Security Regime: Strengthening IoT Device Protection

As the demand for connected devices skyrockets, so does the need to ensure their security. The UK has introduced its Product Security and Telecommunications Infrastructure (PSTI) regime, which came into force on April 29, 2024. This landmark regulatory framework is aimed at securing IoT devices like smart cameras, connected appliances, and fitness trackers. It is …

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Streamline Bluetooth Qualification with QPRDv3: Why IoT Consulting Partners and BlueQ GmbH Are Your Experts

Navigating the new Bluetooth Qualification requirements can be complex, especially with the recent updates under QPRDv3 (Qualification Project Requirements Document version 3). These changes bring new challenges and intricacies for achieving Bluetooth certification for your IoT devices. Key Challenges with QPRDv3 Why IoT Consulting Partners and BlueQ GmbH Are Your Ideal Compliance Partners To tackle …

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Does Your IoT Equipment Need to Comply with the New EU Cybersecurity Regulations? A Manufacturer’s Guide

Does Your IoT Equipment Need to Comply with the New EU Cybersecurity Regulations? A Manufacturer’s Guide

Before you read a NOTE: For more detailed information on the new cybersecurity regulations and how they might impact your devices, check out our comprehensive guides: Is Your IoT Equipment Affected by the New EU Cybersecurity Regulations? With the new EU cybersecurity regulations coming into effect on August 1, 2025, many manufacturers are uncertain whether …

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Beyond CE Compliance: Navigating Global Market Requirements for Radio Devices

Introduction Many Manufacturers assume that once their radio device meets CE compliance, they are set to enter global markets. But while CE compliance is essential for the European market, each region has its own regulatory hurdles. For instance, entering markets like the United States or Canada requires more than just a CE mark. Understanding these …

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Get Ready for the 2025 EU Cybersecurity Regulations: What You Need to Know

Before you read a NOTE: For more detailed information on the new cybersecurity regulations and how they might impact your devices, check out also our comprehensive guides: – Understanding the 2025 Cybersecurity regulations for IOT compliance. – Does you IoT Equipment need to comply with the New EU cybersecurity regulations. As the August 2025 deadline approaches, IoT …

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