North American Certification Mark ETL The listing mark is the primary medical device safety mark in North America. It indicates that your product has undergone independent testing by a Nationally Recognized Testing Laboratory (NRTL) accredited by the U.S. Occupational Safety and Health Administration (OSHA) and complies with applicable safety standards. E
North American Certification Mark
The ETL Listed Mark is the primary medical device safety mark in North America. It indicates that your product has undergone independent testing by a Nationally Recognized Testing Laboratory (NRTL) accredited by the U.S. Occupational Safety and Health Administration (OSHA) and complies with applicable safety standards. The ETL mark encompasses the basic requirements for products sold in the North American market.
IEC 60601-1 (3rd Edition)
The third edition places greater emphasis on risk management, so there are many methods to verify whether a product meets the requirements. Suzhou Arnool testing and certification Ltd. will work with you to help you achieve certification through an interactive risk management approach. From the product development phase through certification, our experts will work with you throughout the entire process on risk management documentation (RMF), electrical safety, electromagnetic compatibility (EMC), testing, and performance evaluation. We hold multiple accreditations, enabling us to provide all major global certification marks and assist you in obtaining the appropriate mark based on market requirements.
CE Mark (applicable to the EU)
The CE mark is a mandatory certification requirement under both the EU Medical Devices Directive (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD). We can help you obtain the CE mark to ensure your products enter the EU market smoothly.
CB Program
As a National Accreditation Body (NCB) and a CB Testing Laboratory (CBTL), Intertek can guide you through the entire testing process and help your products successfully enter target markets in over 41 countries. Intertek maintains a high level of testing scope and capability within the CB system. It currently possesses full testing capabilities for the third edition of the IEC 60601-1 standard and can also provide risk assessment services in accordance with the accompanying standard, ISO 14971.
Safety and Performance Testing of Medical Devices
Our performance testing standards far exceed mandatory requirements. We conduct various accelerated stress tests to determine the specific stress factors (such as temperature, vibration, humidity, or water exposure) that a product can withstand throughout its lifecycle. Collecting this data before the product enters the market helps you better assess risks and avoid costly field failures.
Restriction of Hazardous Substances (RoHS) DirectiveRoHS
We provide RoHS comprehensive testing services, including chemical wet analysis, XRF screening, RoHS product compliance assessment, RoHS product certification (PCS), RoHS implementation of compliance systems, RoHS regulatory consulting and training, and other services.
Electromagnetic Compatibility (EMC) Testing
Our EMC testing experts can perform preliminary scans and assist with troubleshooting. They also provide full compliance testing against the EN/IEC 60601-1-2 EMC compliance requirements for medical electrical equipment and the specific requirements of EN/IEC 60601-2-x.
Biocompatibility ISO 10993
Medical Device Regulatory Services, Management System Certification
Medical Device Management System Audits and Certification
Most countries require manufacturers to have their management systems audited and certified by a third-party organization before selling medical products. But even with a certificate in hand, can you be certain that your system is robust and reliable enough to meet the rapidly evolving needs and constant changes of the medical industry? Yes, you can be certain—if you have obtained a Intertek certificate.
EU Medical DevicesCE (MDD 93/42/EEC)
Before your medical device enters the EU market, it must comply with the essential requirements in Annex 1 of the Medical Devices Directive (MDD) and the standards relevant to your device type.
Medical Devices Regulation (MDR 2017/745)
The new Medical Devices Regulation will take effect following a four-year transition period ending on May 25, 2021. This means that the market access framework will undergo significant changes in all member states of the European Single Market (including the 28 EU member states, the EEA member states of Iceland, Liechtenstein, and Norway, as well as Switzerland through a bilateral agreement). Certification of medical devices under the new Medical Device Regulation (MDR) (2017/745) will be conducted through our new legal entity.
Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) is a set of requirements established by the International Medical Device Regulators Forum (IMDRF) to streamline regulatory burdens and promote key developments by conducting surveillance audits of medical device manufacturers’ quality management systems. Accredited third-party audit bodies conduct a single audit of medical device manufacturers, covering the requirements of ISO 13485:2003 and those of various national regulatory agencies. Regulatory agencies currently participating in the MDSAP pilot program include: the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, the U.S. Food and Drug Administration (FDA), the Japanese Ministry of Health, Labor and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
ISO 13485:2016 Medical Device Quality Management System Certification
The ISO 13485 standard provides manufacturers, designers, and suppliers in the medical device industry with a necessary framework to demonstrate compliance with regulatory requirements and mitigate risks to stakeholders. It places greater emphasis on risk-based thinking and decision-making, while also providing greater internal operability between clauses and requirements.
Why Choose Arnool Testing
Arnool has a team of reliable technical experts and collaborates with multiple international laboratories, enabling it to provide fast, flexible, and cost-effective local consulting services worldwide.
We can provide safety testing, inspection, and certification consulting services in the world’s two major markets—Europe (CE, GS) and North America (UL, ETL)—we can provide testing, inspection, and certification consulting services. Additionally, in accordance with relevant international and national standards, we offer testing and certification consulting services to help mechanical products enter more countries and regions, such as those along the Belt and Road Initiative.
Through the guidance and advice of our experts, we can assist you in obtaining certification for the same product across multiple markets, avoiding duplicate testing and thereby significantly reducing time and costs while gaining a competitive advantage.
We provide fast and practical solutions tailored to our clients’ needs. Our experience and commitment to customer service ensure that your requirements and timelines are met, while allowing you to enjoy flexible and personalized service.