To run a successful business, you want to make and distribute products that are at the right quality standard and that comply with the regulations of the countries of sale. I guess nobody will argue with that. But what do "Quality and Compliance" mean, in practice? They are often separated under different functions inside the same company. Why? Let's look at these 2 concepts in the context of manufacturing products and importing them. … [Read more...]
Who’s liable for product safety, buyer or manufacturer? [Podcast]
![Who's liable for product safety, buyer or manufacturer? [Podcast]](https://qualityinspection.org/wp-content/uploads/2021/10/WhosliableforproductsafetybuyerormanufacturerPodcast-1140x445.jpeg)
In this episode… Renaud Anjoran is joined by two guests in this episode, Clive Greenwood and Andrew Wilson of WWMG associates, and they're going to get to the bottom of who is liable for product safety issues. Some importers work with manufacturers in China and make certain assumptions about their level of liability, especially if the manufacturer has been involved in product design and development. It depends on a number of things, such as who has the design authority and who issues the design … [Read more...]
If The EU MDR Is Product Compliance’s Future – Be Afraid, Be Very Afraid! [Podcast]
![If The EU MDR Is Product Compliance's Future - Be Afraid, Be Very Afraid! [Podcast]](https://qualityinspection.org/wp-content/uploads/2021/07/IfTheEUMDRIsProductCompliancesFuture-BeAfraidBeVeryAfraidPodcast-1000x445.jpeg)
In this episode... Renaud Anjoran is joined again by Clive Greenwood, an expert in product compliance for a new episode following on from the first episode they recorded about product compliance (which covered the main compliance challenges faced by importers). This time they're looking at the future of compliance standards by examining the new Medical Device Regulation (EU) 2017/745 (MDR), an extremely comprehensive and stringent regulation. They believe this 'MDR' signposts how future … [Read more...]
Common Compliance Gaps & Loopholes With ‘Made In China’ Products [Podcast]
In this episode... Renaud Anjoran is joined by Clive Greenwood, an expert in product compliance to discuss the issues with compliance that most importers face and some compliance gaps and 'loopholes' to be aware of. Many people buy products from China (or elsewhere) without checking if they are compliant with their country's rules and regulations. This means that a lot of products are being Just hit the play button to start listening..! Listen to the episode right here … [Read more...]
New EU Medical Device Regulation: No More Traders?
If you have been buying China-made medical devices and reselling them in the European Union, and if you haven't actually done the product development work yourself, can you keep doing that business now that the new EU medical device regulation changes have come into effect? In many cases, no. … [Read more...]
Product Safety When Buying from China: Avoid Negligence
Dan Harris wrote an article about product safety (How to Reduce Your Foreign Manufactured Product Liability Risks) that will, hopefully, open the eyes of many people to the risks they are exposed to. I thought it particularly interesting because he went through typical questions asked of importers that resold unsafe products: To convince recalcitrant clients of the need for product liability protection for the products they are having made overseas, I sometimes send them the following … [Read more...]
You Need To Know About UKCA If You Sell Products In The UK
Many companies have been selling their products with a CE mark in the European Union and in the UK. They are in for a big shock as the UKCA mark comes into force to supersede CE in the UK! … [Read more...]
Investigating the Causes of Product Failure and Improving Design
You conduct reliability tests on your new products. You and your suppliers do product inspections and laboratory tests on mass production orders. Your customers probably give you feedback on the issues they find on what you ship to them. You collect many data this way. You set aside samples that don't pass. But do you learn from this? One of the most important activities is the investigation of the causes of product failure when certain samples fail the inspections/tests or fail in the hands of … [Read more...]
What Is Compliance Testing? [Podcast]
Why is compliance testing so important for buyers who import products from China? Compliance testing helps assure your product's compliance with your market's product and safety standards. By conducting such testing, you'll be testing whether the product is safe for consumers under normal use, doesn't contain hazardous substances above acceptable levels, and won't be restricted from being imported. Because importers are usually held responsible for any safety problems caused by … [Read more...]