Certification Experts
Product Certification Approval CE Mark

Introducing CQC for Chinese certification

For many years Certification Experts has provided exporters to China a complete set of professional certification and compliance services. With offices in China and around the globe, our experts can help you navigate the complex procedures required for exporting to China, making your transactions easier and your trade more efficient. Our comprehensive set of services

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Product Certification Approval CE Mark

9 INTERESTING FACTS ABOUT CE MARKING

The standards for certification are compiled at national, European and international level. There are more than 100,000 standards that are regularly revised. Manufacturers, importers, and distributors often wonder what standards apply to their product, below you will find out 9 interesting facts about CE marking . Our technical and legal experts determine the correct standards

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Product Certification Approval CE Mark

Hello new office!

Our newly build European office located in Breukelen, the Netherlands is coming along quite nicely. Due to good weather and enthusiastic construction workers the new premises is taking shape very quick. As with all things: the foundation is key, after all ‘you can’t build a great building on a weak foundation’ Please see below the

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Product Certification Approval

The CB-Scheme for worldwide market access

The CB-Scheme is an international system for mutual recognition of test reports and certificates for the safety of electric and electronic components, equipment and products. The system is a multilateral agreement between participating countries and certification entities. The CB-scheme is initiated by the International Electrotechnical Commission (IEC). The CB-Scheme allows companies to gain market access

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Product Certification Approval

Stepping Stones for Exporting Products to China

With the increasing economic development of the Chinese market, the trend for exporting of products to China is growing. All governmental departments, including the Chinese government, exercise control over the import of goods to its internal market. However, there are many regulations and administrative procedures that should be taken into account. Certification Experts developed complete

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Product Certification Approval CE Mark

FDA and CE approval

Many Medical Device companies struggle with how to comply with both US FDA’s regulations and the European Union’s (EU) Medical Device Directive (MDD). They face the challenge on how to bridge the gaps between these regimes in order to acquire product access in both markets. Common goal Companies who have obtained a FDA premarket approval

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Product Certification Approval CE Mark

Quality Management System for Medical Devices and ISO 13485

ISO 13485 is a standardization guideline furnished by the International Organization for Standardization to establish a quality management system for medical devices. The certification was first introduced in 1996. From then on, more than 26,000 companies have gotten ISO 13485 certificates, issued by accredited organizations worldwide.

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Instructions for medical devices

Instructions for Use and Medical Devices

 CE marking on medical devices indicates that they comply with the applicable European legislation with regard to product safety. Part of the CE marking process is drafting the Instruction For Use (Hereafter: IFU). The IFU provides general information on the use of the medical device as well as safety information including warnings. The Medical Devices

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Product Certification Approval CE Mark

Does Brexit change your position as a distributor?

A new draft treaty has been reached between the European Union and the United Kingdom (UK) for a large part of the conditions surrounding the Brexit. There has been agreements on the rights of EU citizens in the UK, and further UK citizens in the EU and the financial settlement of UK withdrawal. For the

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quality management systems for medical devices

Outsourcing your ISO13485 Quality Management system?

A growing number of organizations are challenged with keeping up with their quality management system for medical devices. Over the last few months we have received multiple questions within our network whether we can maintain the implemented quality management system. This question often relates to a quality management system in accordance with the ISO 13485

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