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Tag Archives: product compliance
How to Comply with CE and UKCA? [Podcast]
Renaud and Adrian discuss CE and UKCA compliance. These are EU and British regulations for product safety, health, and environmental requirements. If you sell products in these markets you’ll need to add the CE or UKCA mark to them, so … Continue reading
Posted in Sofeast Podcast
Tagged ukca mark, eu regulations, ce mark, product compliance
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Exploring Product Safety & Reliability Issue Liability [Podcast]
Sofeast’s CEO Renaud Anjoran is joined by two guests, Clive Greenwood and Andrew Wilson of WWMG associates to discuss the topic of liability for product safety issues. There’s commonly a disconnect between Chinese manufacturers and their foreign customers over who … Continue reading
Posted in Sofeast Podcast
Tagged product testing, product compliance, product safety
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How Many Product Samples Do We Really Need To Test For Reliability And Compliance?
You need to be aware that during new product development, and also during mass production runs, a number of samples will need to be tested in different ways. The objective is generally to assure their quality, their reliability, and their safety, … Continue reading
Stainless steel bottle testing for safety & compliance. How is it done?
Stainless steel bottle testing is something importers need to get right as they’re classed as a food contact material product (FCM). They’re a hot product and something we’re asked about quite regularly. In this post, we’ll explain the kinds of … Continue reading
Posted in Product Safety
Tagged product testing, product safety regulations, product compliance
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New EU MDR: Who Are The “Economic Operators” For Imported Devices?
Since May 2021, the New EU MDR Medical Device Regulation 2017/745 is in place. One of its objectives has been improving the safety of users and patients. And one way to achieve that objective is ensuring that all the parties involved … Continue reading
Posted in EU MDR
Tagged importing into the eu, eu mdr, medical devices, compliance, product compliance, importing from china, ppe
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EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?
If you make, import, or distribute products that end up on the European Union market, and if your products may be categorised as medical, you need to be very clear about that. As we discussed recently, the companies involved in … Continue reading
Posted in EU MDR
Tagged medical device classes, ce mark, importing into the eu, eu mdr, medical devices, product compliance, product safety
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How The EU MDR Will Change The Medical Device Industry Forever [Podcast]
Our CEO Renaud is joined again by Clive Greenwood, a China-based product compliance expert, to discuss the new EU MDR. We all heard about the Wild West of PPE imports in the early days of the pandemic where worrying amounts of substandard … Continue reading
Posted in EU MDR, Sofeast Podcast
Tagged eu mdr, medical devices, compliance, product compliance, product safety, sourcing ppe, importing from china, ppe
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Product Compliance For Made-In-China Products [Podcast]
In This Episode… If you’re getting your products made in China (or other Asian countries like Vietnam) you as an importer should be very concerned about whether they’re compliant with the country they’re being sold in’s safety rules and regulations. So … Continue reading
11 Common Electronic Product Certification And Compliance Requirements
Regulatory electronic product certification requirements can present challenges for organizations looking to design, develop and market electrical and electronic products in different countries around the world. As these requirements are primarily focused on particular products, use cases and generally the … Continue reading
How Important Are Safety/Compliance Laboratory Certifications For Your Made-In-China Product?
While developing and manufacturing a new product in China, it is worthwhile trying to get laboratory certifications that demonstrate the safety and compliance of your products. Why? It’s about your liability and about what your customers will think of your … Continue reading
