At the conference, Klemen Štibernik (SIQ metrology lab) presented the paper Traceable AM Modulation Index Measurement, which attracted considerable interest from the participants.

The paper presents a method for the accurate and traceable determination of the amplitude modulation index of electrical signals. The developed solution enables reliable and internationally comparable measurements and contributes to further advances in electromagnetic metrology.

Find out more: CPEM 2026.

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The final product must operate safely and reliably under all intended conditions of use, whether it is a simple medical device or a complex piece of equipment. Medical device safety must be addressed and managed throughout the entire product life cycle – from design and development to testing, manufacturing and use. Manufacturers must therefore take numerous technical, clinical and regulatory requirements into account from the earliest stages of development.

As an independent testing and certification body and a notified body for medical devices, SIQ provides manufacturers with a broad range of medical device assessment and testing services. These range from conformity assessment under Regulation (EU) 2017/745 (MDR) to electrical safety testing, electromagnetic compatibility (EMC) testing, cybersecurity testing, and training on the interpretation of applicable standards and regulatory requirements. By bringing expertise and testing capabilities together in one place, SIQ can support manufacturers in assessing various aspects of product safety throughout the entire product life cycle.

Electricity – a risk we rarely think about

One of the key elements in medical device verification is electrical safety testing. Electrical and electronic medical devices are verified to determine whether they are designed so that, when used as intended, they do not pose unacceptable risks to patients or users. This includes assessing protection against electric shock, the adequacy of insulation, and hazards associated with overheating, fire and mechanical effects.

Particular attention is also paid to parts of the device that come into direct contact with the patient, as these must provide an appropriate level of protection even in the event of a single fault. Testing therefore confirms that the protective measures are effective not only during normal operation but also under reasonably foreseeable adverse conditions.

Experts involved in the assessment process

The European Medical Device Regulation (MDR) sets out the requirements manufacturers must meet before placing their medical devices on the European Union market. For each device, manufacturers must demonstrate compliance with the general safety and performance requirements. This means identifying and evaluating risks, demonstrating the safety and performance of the device under its intended conditions of use, and preparing comprehensive technical documentation.

Due to its complexity, the conformity assessment process can be lengthy and may take more than a year and a half, as the notified body must thoroughly assess compliance with the requirements relating to the safety and performance of the device.

In addition to reviewing the technical documentation, an important part of the process is the assessment of the clinical evaluation, through which the manufacturer uses appropriate clinical evidence to demonstrate that the device is safe and clinically effective for its intended purpose. Depending on the type of device, the assessment process involves experts from a range of disciplines, including sterilisation, biocompatibility, electrical safety and electromagnetic compatibility, software, artificial intelligence, and other relevant technical fields. Depending on the device’s intended purpose, medical specialists from the relevant clinical field are also involved.

“When assessing the safety and conformity of an EEG device, expertise from a wide range of disciplines may come together – from neurologists and other clinical experts to specialists in biomedical engineering, electrical safety, electromagnetic compatibility, software and cybersecurity. It is precisely this interdisciplinary approach that enables a comprehensive assessment of a medical device,” explains Peter Kramar, PhD, Director of Medical Device Certification at SIQ.

As devices become increasingly connected, there can be no compromise on safety

All these areas of expertise are becoming increasingly interconnected in modern medical devices, which are growing more complex and increasingly dependent on software and connectivity. Many devices are now connected to the cloud via the internet and use technologies such as artificial intelligence. There is also a growing number of active medical devices that connect wirelessly to smartphones and other devices.

As connectivity increases, cybersecurity is becoming an increasingly important aspect of ensuring safety. Medical devices must be protected against unauthorised access, cyberattacks and other cyber threats, as these can affect not only the operation of the device but also user safety and data protection.

For electronic and wirelessly connected medical devices, electromagnetic compatibility and efficient use of the radio spectrum must also be ensured. A medical device must operate reliably without interfering with other devices in its environment. At the same time, wireless communication functionalities must be appropriately tested and meet requirements that ensure their safe and reliable operation.

Artificial intelligence offers significant benefits but requires new safety mechanisms

Artificial intelligence is also playing an increasingly important role. More and more manufacturers are incorporating AI-based solutions into existing medical devices or using AI to enhance their functionality. This opens up new opportunities for the development and use of medical devices, while at the same time introducing new challenges relating to their safety, reliability and performance.

With the implementation of the European Artificial Intelligence Act (AI Act, Regulation (EU) 2024/1689), medical devices incorporating artificial intelligence will also be subject to additional requirements. In addition to existing medical device requirements, manufacturers will need to address aspects relating to safety, performance and the management of risks arising from the use of artificial intelligence. This will further reinforce the need for a comprehensive and interdisciplinary approach to the development, assessment and conformity assurance of modern medical devices.

Regulation is essential for patient safety and continued development

The safety of a medical device is the result of combining regulatory requirements, clinical and other specialist expertise, and various areas of technical testing. With its expertise and broad range of services, SIQ supports manufacturers in addressing different aspects of conformity assessment and safety verification – from MDR conformity assessment to electrical safety, electromagnetic compatibility and cybersecurity testing.

The ultimate goal is to ensure that the device fulfils its intended purpose and that its use is safe and reliable for both patients and healthcare professionals. Cooperation between experts from different disciplines and independent assessment are essential in achieving this goal, enabling an objective evaluation of all relevant aspects of medical device safety.

The post From Development to Patient: Ensuring the Safety of Medical Devices appeared first on SIQ.

Another important milestone is the start of our cooperation with Hager Group, one of Europe’s leading providers of solutions for building electrification, electrical distribution, and energy management. Through their solutions, Hager makes an important contribution to the transition towards a more electrified, connected, and energy-efficient future, while increasingly focusing on rapidly growing areas such as energy management, energy storage systems, electric vehicle charging infrastructure, and smart building solutions.

During the summer months, we carried out a substantial number of calibrations of Hager’s measurement equipment at the company’s premises, successfully laying the foundations for further cooperation with this international group, which employs approximately 13,000 people, operates in more than 100 markets, and generates annual revenues of around EUR 3 billion.

The extension of our high-frequency capabilities and the acquisition of new customers are important steps in pursuing our development strategy. With new competencies and cooperation with companies operating in rapidly growing technology and industrial sectors, new opportunities are opening for our further growth, development, and extension. These achievements are something we can justifiably be proud of.

The post Metrology | Extension of High-Frequency Capabilities and New Strategic Partnerships appeared first on SIQ.

While the final production URL for submitting notifications has not yet been published, ENISA has already made available information on the Single Reporting Platform (SRP). Registration guidance, reporting instructions, and information on notification formats and processes are already available.

Organizations affected by the CRA are encouraged to familiarize themselves with the reporting requirements and prepare their internal processes before the reporting obligations take effect.

More information

The post Reminder: CRA Reporting Obligations Start on 11 September 2026 appeared first on SIQ.

In many industries, measuring and testing equipment represents a significant investment and is essential for ensuring product quality, safety, and regulatory compliance. For permanently installed or highly sensitive systems, transporting equipment to the SIQ laboratory may introduce unnecessary risks and disrupt operations.

On-site calibration eliminates these risks by performing calibration directly at the customer’s premises. This approach avoids mechanical damage, changes in metrological characteristics caused by transportation, and additional interventions required when reinstalling the equipment.

Another key advantage is the significant reduction in downtime. Calibration can be scheduled during planned maintenance windows or performed simultaneously on multiple systems, minimizing production interruptions and maximizing equipment availability.

In environments such as cleanrooms, GMP-compliant manufacturing facilities, or safety-critical systems, on-site calibration also preserves existing validated conditions. Equipment remains within its actual process environment, eliminating the need for revalidation or system adjustments following transportation.

SIQ performs on-site calibrations in accordance with the requirements of ISO/IEC 17025, ensuring traceability to the SI units, documented evaluation of measurement uncertainty, and the use of validated procedures specifically developed for field calibration. This guarantees a level of technical validity equivalent to laboratory-based calibration.

Beyond technical compliance, on-site calibration also enhances collaboration. Direct interaction between SIQ experts and the customer’s engineers enables immediate clarification of measurement requirements, optimization of instrument settings, and the exchange of practical expertise. This frequently results in a better understanding of measurement processes and supports long-term operational improvements.

On-site calibration is particularly beneficial for large or permanently installed systems, equipment located in controlled environments, and where equipment transportation would require revalidation or compromise process integrity.
Through this approach, SIQ combines metrological expertise, reduced operational risk, and support for uninterrupted process continuity—delivered directly at the customer’s site.

On-site calibration reduces operational downtime, minimizes the risks associated with equipment transportation, and provides reliable, traceable measurements directly within the customer’s operating environment.

Contact our team of experts to receive a quote. Find out more about our accredited calibrations HERE.

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The Safety and Electromagnetics programme offered a rich agenda of technical presentations and workshops across four key product groups: ITAV (Information Technology and Audio/Video Equipment), MED/MEAS (Medical and Measurement Equipment), LITE (Lighting Products), and HOUS/TOOL (Household Appliances and Tools). Participants gained valuable insights into the latest developments in electrical safety, EMC, international approval requirements, product standards, cybersecurity, ecodesign legislation, and practical approaches to compliance. The programme also featured hands-on workshops on electrical safety and EMC, allowing attendees to deepen their technical knowledge through practical examples and real-world case studies.

The conference brought together technical experts from product development, testing, certification, and international approvals. Beyond the technical programme, the Summit served as an important meeting point for industry professionals and SIQ experts. Participants had the opportunity to discuss specific technical challenges, connect directly with SIQ specialists from different fields, and exchange experiences and best practices with their peers.

We would like to sincerely thank all speakers, partners, and participants for joining us and contributing to the success of SIQ Summit 2026. The strong attendance, high level of engagement, and positive feedback confirmed the value of bringing together experts from across industries to share knowledge and address the challenges of an increasingly complex compliance landscape.

We look forward to welcoming you again at future SIQ events.

The post SIQ Summit 2026: Safety and EMC Experts Exchange Knowledge and Experience appeared first on SIQ.

The assessment, performed by the European Testing, Inspection and Certification System (ETICS), confirmed SIQ’s continued compliance with the applicable requirements for participation in European certification schemes. The positive outcome demonstrates SIQ’s ongoing commitment to maintaining a high level of technical competence and quality in conformity assessment services.

SIQ is an active and long-standing participant in leading European certification schemes and operates within the frameworks of the following schemes:

• ENEC Scheme
• ENEC+ Scheme
• CCA – CENELEC Certification Agreement
• CCA EMC Scheme
• CIG Inspection Scheme

Through its participation in these schemes, SIQ provides internationally recognized testing and certification services, supporting manufacturers in obtaining recognized European certification marks for electrical products that demonstrate compliance with European standards.

More information:
Matej Žontar
E-mail: matej.zontar@siq.si
Tel.: +386 1 4778 251

The post SIQ Ljubljana Successfully Completes ETICS Reassessment appeared first on SIQ.

What has changed?
The FCC will no longer grant standard equipment authorization for certain foreign-manufactured routers. Instead, manufacturers must obtain additional approvals from relevant U.S. authorities before these products can be placed on the market.

The measure applies primarily to routers used in homes and small office environments, which are widely deployed and often serve as critical entry points to networks.

Importantly, devices already approved or currently in use are not affected and can continue to operate and receive updates.

What does this mean for industry?
This update reflects a broader global trend of increasing regulatory attention on cybersecurity and supply chain transparency.

Manufacturers and stakeholders should:

• review their production and sourcing strategies,
• evaluate compliance requirements for the U.S. market
• strengthen cybersecurity measures throughout the product lifecycle.

FCC announcement

FCC FAQ

More information:
Marjan Mak
E-mail: marjan.mak@siq.si
Tel.: +386 1 4778 178

The post FCC applies restriction for Foreign-Manufactured Routers appeared first on SIQ.

Manufacturers of power-supply units (PSUs) and DC/DC converters are therefore facing new challenges related to safety certification. The most commonly used safety standard for products in data-center environments is IEC 62368-1, which applies to audio/video, information and communication technology equipment. However, IEC 62368-1 is limited to equipment with a rated voltage not exceeding 600 V; therefore, equipment with an 800 V DC rated input or distribution interface falls outside its scope.

As a result, manufacturers are looking for alternative standards. One such option is IEC 62477-1, which covers power electronic converter systems and equipment and applies to rated system voltages up to 1 000 V AC or 1 500 V DC.

SIQ Ljubljana is accredited for both of the above-mentioned standards and participates in the IECEE CB Scheme. We can support certification of products with power ratings up to 400 kW. In addition to safety approvals, we also provide EMC and environmental testing services. Furthermore, we support short-circuit current testing in cooperation with our partner laboratories.

More information:
Boštjan Glavič
E-mail: bostjan.glavic@siq.si
Tel.: +386 1 4778 265

The post 800 V DC Distribution in Data Centers: Scope Limitations of IEC 62368-1 appeared first on SIQ.

Key requirements focus on protection against high temperatures, pressurized systems, hazardous chemicals, and risks related to fluid handling. Testing typically covers aspects such as leakage, mechanical strength, abnormal operation, and protection against operator exposure to heat and chemicals. A major challenge lies in addressing multiple interacting hazards within a single system, requiring a comprehensive safety approach.

Manufacturers often face difficulties in demonstrating compliance under realistic operating conditions, especially when designing compact systems with complex process cycles. Another challenge is ensuring durability and consistent performance under aggressive environments, such as exposure to steam, disinfectants, and corrosive substances.

Testing is essential not only for regulatory compliance, but also for ensuring operator safety, reducing liability, and enabling global market access.

SIQ is accredited for testing according to IEC 61010-2-040 and have this standard also within our CB Scheme scope, enabling efficient and internationally recognized certification.

We support our customers with:

• early design reviews and gap analysis,
• pre-compliance and full safety testing,
• certification support for international markets.

Applicable standards:

• IEC 61010-1:2010 + A1:2016
• EN IEC 61010-1:2010 + A1:2019
• IEC 61010-2-040:2020
• EN IEC 61010-2-040:2021

More information:
Matej Šmidovnik
E-mail: matej.smidovnik@siq.si
Tel.: +386 1 4778 267

The post Safety Testing of Sterilizers and Washer-Disinfectors according to IEC 61010-2-040 appeared first on SIQ.